Pump, Breast, Powered

FDA product code HGX · 241 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.5160
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-10-03 – 2026-09-17

HGX 2022-05-26

Wearable Breast Pump (Model S9)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K220596

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HGX 2022-05-06

Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K212564

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HGX 2022-04-15

ARDO Alyssa

Applicant Ardo Medical AG

K number K212773

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HGX 2022-03-15

Fit Pro Breast Pump

Applicant Hygeia II Medical Group, Inc.

K number K212955

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HGX 2022-02-11

Wearable Breast Pump (Model S12)

Applicant Shenzhen TPH Technology Co., Ltd.

K number K212180

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HGX 2022-02-11

Electric Breast Pump

Applicant Shantou Huihengqi Electronic Technology Co., Ltd.

K number K211024

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HGX 2022-02-09

Lucy Breast Pump

Applicant Willow Innovations, Inc.

K number K213311

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HGX 2022-01-20

Electric breast pump

Applicant Dongguan Rongfeng Medical Co., Ltd.

K number K212884

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HGX 2021-12-01

Electric Breast Pump

Applicant Zhejiang Carebao Co., Ltd.

K number K211755

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HGX 2021-10-19

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

Applicant Uzinmedicare Co.

K number K210124

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HGX 2021-08-26

TT Electric Breast Pump, TT Double Electric Breast Pump

Applicant Wuxi Xinzhongrui Baby Supplies Co., Ltd.

K number K202802

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HGX 2021-08-25

Elvie Stride

Applicant Chiaro Technology Limited

K number K210936

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HGX 2021-08-11

Solo, Swing Maxi

Applicant Medela, LLC

K number K210759

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HGX 2021-07-08

Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K number K203148

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HGX 2021-05-04

Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K201152

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HGX 2021-04-22

Mya Joy PLUS Breast Pump

Applicant Ameda, Inc.

K number K203570

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HGX 2021-04-09

Electric breast pump (Models: RH-228 and RH-338)

Applicant Cixi Ruihong Electric Appliance Co., Ltd.

K number K201903

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HGX 2021-03-01

imani i2

Applicant Imani Co.

K number K202037

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HGX 2021-02-26

imani i1

Applicant Imani Co.

K number K202045

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HGX 2021-02-10

Hi bebe super (Models BT-150S and BT-150L)

Applicant Bistos Co., Ltd.

K number K200675

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HGX 2020-12-15

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K number K203383

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HGX 2020-10-01

Philips Avent Single/Double electric breast pump Advanced

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K number K201381

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HGX 2020-09-11

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K193449

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HGX 2020-06-15

Pump In Style

Applicant Medela, LLC

K number K200508

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HGX 2020-04-17

Rumble Tuff Electric Breast Pump

Applicant A Cute Baby, Inc.

K number K200712

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HGX 2020-03-30

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump

Applicant Guangzhou Yongyi Industrial Co., Ltd.

K number K192640

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HGX 2020-03-18

Evolve Breast Pump

Applicant Hygeia II Medical Group, Inc.

K number K200406

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HGX 2020-01-22

Spectra Q

Applicant Uzinmedicare Co.

K number K191109

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HGX 2020-01-16

Electric Breast Pump

Applicant Ningbo Huiyoo Baby Products Co., Ltd.

K number K191802

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HGX 2019-10-18

Evolve Breast Pump

Applicant Hygeia II Medical Group, Inc.

K number K190465

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HGX 2019-10-17

Freestyle Flex

Applicant Medela AG

K number K191653

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HGX 2019-10-11

Spectra Cashmere

Applicant Uzinmedicare Co.

K number K191208

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HGX 2019-09-06

Willow Wearable Breast Pump 2.0

Applicant Exploramed Nc7, Inc.

K number K191577

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HGX 2019-08-30

OPERA, OPERA eco

Applicant Unimom.Co

K number K190810

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HGX 2019-06-12

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

Applicant Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

K number K182749

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HGX 2019-03-07

Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K182413

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HGX 2018-11-30

Spectra S3 Plus

Applicant Uzinmedicare Co.

K number K181784

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HGX 2018-10-16

Pump In Style Advanced, Advanced Personal Double Breastpump

Applicant Medela, LLC

K number K181937

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HGX 2018-10-10

Elvie Pump

Applicant Chiaro Technology Limited

K number K181863

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HGX 2018-08-06

MINUET LCD, MINUET LCD eco

Applicant Unimom.Co

K number K180075

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HGX 2018-06-18

GCE704 Breast Pump

Applicant Globalcare

K number K172842

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HGX 2018-04-04

The Pump by Babyation

Applicant Babyation, LLC

K number K173699

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HGX 2017-12-20

Electric Breast Pump

Applicant Joytech Healthcare Co. , Ltd.

K number K172989

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HGX 2017-11-29

One Mum Pumpset

Applicant Ardo Medical AG

K number K172067

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HGX 2017-10-13

Freemie Independence, Freemie Liberty

Applicant Dao Health

K number K172772

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HGX 2017-10-02

Yooeehouse Breast Pump

Applicant Nantong Poly Technology Co., Ltd.

K number K163183

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HGX 2017-08-28

Moxxly Flow Collection System

Applicant Moxxly, Inc.

K number K170722

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HGX 2017-07-31

Youha electric breast pump

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K number K163136

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HGX 2017-03-15

Spectra 9Plus

Applicant Uzinmedicare Company

K number K162415

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HGX 2017-03-07

CIMLRE F1 and CIMILRE S3

Applicant Cimilre Co., Ltd.

K number K162870

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HGX 2016-12-08

Proture Double Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K162747

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HGX 2016-10-28

Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail

Applicant Medela, Inc.

K number K161725

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HGX 2016-09-01

Hi bebe plus

Applicant Bistos Co., Ltd.

K number K160274

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HGX 2016-08-29

Philips Avent Comfort Single/Twin Electric Breast Pump

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K number K161532

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HGX 2016-08-11

Athena Breast Pump

Applicant Exploramed Nc7, Inc.

K number K161266

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HGX 2016-06-24

Naya Breast Pump System

Applicant Naya Health, Inc.

K number K160511

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HGX 2016-04-15

Spectra S1Plus and Spectra S2 Plus

Applicant Uzinmedicare Co.

K number K150476

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HGX 2013-09-06

FREEMIE BREAST COLLECTION SYSTEM

Applicant Dao Health

K number K130349

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HGX 2013-06-18

EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP

Applicant Evenflo Feeding Incorporated

K number K131153

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HGX 2013-05-30

MEMORY PUMP MODEL Y4947

Applicant Tomy International

K number K131027

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HGX 2013-04-05

NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP

Applicant Mapa GmbH

K number K121478

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HGX 2012-12-28

LANSINOH POWERED ELECTRIC BREAST PUMP

Applicant Lansinoh Laboratories Saglik Gerecleri Tasarim San

K number K122474

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HGX 2012-11-20

RUMBLE TUFF

Applicant Acute Ideas Co. , Ltd.

K number K113315

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HGX 2012-05-31

CLOSER TO NATURE

Applicant Mayborn Group Limited

K number K121322

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HGX 2012-05-10

LUCINA-MELODI

Applicant Genadyne Biotechnologies, Inc.

K number K112856

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HGX 2012-02-17

CLOSER TO NATURE ELECTRIC BREAST PUMP

Applicant Mayborn Group Limited

K number K113664

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HGX 2012-02-01

FREEMIE (R)

Applicant Dao Health

K number K111411

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HGX 2011-08-11

LUCINA MODEL MELODI

Applicant Genadyne Biotechnologies, Inc.

K number K102516

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HGX 2011-03-11

TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP

Applicant Mayborn Baby and Child / Jackel International, Ltd.

K number K110343

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HGX 2010-12-22

SIMPLYGO BREAST PUMP

Applicant Evenflo Company, Inc.

K number K102600

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HGX 2010-09-17

E-BASIC SINGLE BREAST PUMP

Applicant Mapa GmbH

K number K101157

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HGX 2010-08-13

SPECTRA SERIES BREAST PUMP

Applicant Uzinmedicare Co.

K number K093145

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HGX 2010-07-14

SIMPLISSE ELECTRIC BREASTFEEDING COMPANION

Applicant Simplisse, Inc.

K number K093648

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HGX 2010-06-16

UNIMOM ALLEGRO

Applicant Blue Egg CO

K number K100929

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HGX 2010-05-28

AMEDA PLATINUM BREAST PUMP

Applicant Evenflo Company, Inc.

K number K100435

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HGX 2010-03-24

NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP

Applicant Luv N' Care, Ltd.

K number K100385

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HGX 2009-10-22

DEBP

Applicant Enko , Ltd.

K number K092783

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HGX 2009-10-09

SIMPLYGO HANDS FREE BREAST PUMP

Applicant Evenflo Company, Inc.

K number K092770

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HGX 2009-02-06

MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP

Applicant Medel S.P.A.

K number K081463

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HGX 2009-01-22

ENDEARE BREAST PUMP

Applicant Hygeia Medical, Inc.

K number K081932

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HGX 2008-10-09

MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B

Applicant Learning Curve Brands Inc. the First Years

K number K082802

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HGX 2008-09-11

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

Applicant Evenflo Company, Inc.

K number K082307

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HGX 2007-07-17

DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400

Applicant Whittlestone, Inc.

K number K070435

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HGX 2006-08-15

PLAYTEX EMBRACE PETITE BREAST PUMP

Applicant Playtex Products, Inc.

K number K061013

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HGX 2006-05-02

MEDELA SWING BREAST PUMP

Applicant Medela AG

K number K053052

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HGX 2005-12-12

LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP

Applicant Limerick, Inc.

K number K051926

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HGX 2005-11-01

EVENFLO ELAN BREAST PUMP

Applicant Evenflo Company, Inc.

K number K052909

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HGX 2005-09-22

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101

Applicant Avent America, Inc.

K number K052047

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HGX 2005-09-07

WHITTLESTONE EXPRESSER

Applicant Whittlestone, Inc.

K number K051112

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HGX 2005-08-29

ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100

Applicant Avent America, Inc.

K number K051413

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HGX 2004-12-15

GERBER DOUBLE ELECTRIC BREAST PUMP

Applicant Gerber Products Co.

K number K043098

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HGX 2003-10-30

NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

Applicant The First Years, Inc.

K number K033131

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HGX 2003-09-15

NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP

Applicant The First Years, Inc.

K number K032566

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HGX 2003-06-06

MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

Applicant Medela, Inc.

K number K031614

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HGX 2003-01-10

LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002

Applicant Limerick, Inc.

K number K021739

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HGX 2002-12-02

EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

Applicant Evenflo Company, Inc.

K number K022933

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HGX 2002-11-01

PLAYTEX BREAST PUMP

Applicant Playtex Products, Inc.

K number K022594

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HGX 2002-09-30

WHISPER WEAR BREAST PUMP

Applicant Whisper Wear

K number K022140

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HGX 2002-05-03

THE NURTURE III BREAST PUMP

Applicant Bailey Medical Engineering

K number K020375

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HGX 2002-03-07

MEDELA SYMPHONY BREAST PUMP, MODEL 024

Applicant Medela, Inc.

K number K020518

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