Pump, Infusion, Elastomeric

FDA product code MEB · 87 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1992-03-26 – 2026-04-24

MEB 2026-04-24

SMARTeZ™ Elastomeric Infusion Pump (RS series)

Applicant Epic Medical Pte. , Ltd.

K number K250234

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MEB 2024-11-05

InfuLife

Applicant First Medical Source, LLC

K number K240624

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MEB 2024-10-07

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

Applicant Epic Medical Pte. , Ltd.

K number K242152

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MEB 2019-03-22

ON-Q* Pump with Bolus

Applicant Halyard Health

K number K181360

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MEB 2016-04-04

SMARTez elastomeric infusion pump

Applicant Epic Medical Pte. , Ltd.

K number K151650

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MEB 2013-08-14

MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM

Applicant Mfs - Medical Flow Systems, Ltd.

K number K131247

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MEB 2009-04-30

MODIFICATION TO AUTOFUSER

Applicant Ace Medical Us, LLC

K number K090300

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MEB 2008-07-15

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP

Applicant Westmed, Inc.

K number K081905

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MEB 2008-02-19

ALPHA INFUSION PUMP, MODEL A200, A450

Applicant Advanced Infusion, Inc.

K number K071532

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MEB 2007-11-26

DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM

Applicant Symbios Medical Products, LLC

K number K072921

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MEB 2007-11-06

SMARTBLOCK PAIN PUMP

Applicant Medical Flow Systems, Ltd.

K number K072053

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MEB 2007-07-19

MODIFICATION TO DISPOSABLE INFUSION PUMP KIT

Applicant Symbios Medical Products, LLC

K number K071735

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MEB 2007-05-25

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES

Applicant Baxter Healthcare Corp

K number K071222

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MEB 2007-01-26

ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP

Applicant I-Flow Corp.

K number K063530

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MEB 2006-10-18

STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20

Applicant Advanced Infusion, Inc.

K number K061661

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MEB 2006-09-21

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

Applicant Baxter Healthcare Corporation

K number K062457

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MEB 2006-06-16

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET

Applicant Precise Medical Products, Ltd.

K number K061409

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MEB 2006-05-30

AUTOFUSER

Applicant Ace Medical Us, LLC

K number K060258

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MEB 2006-05-09

SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

Applicant Apex Medical Technologies, Inc.

K number K060933

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MEB 2006-03-22

SEMPERFLO INFUSION SYSTEM

Applicant ETHICON, Inc.

K number K052999

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MEB 2005-12-15

NIPRO SUREFUSER AMBULATORY INFUSION PUMP

Applicant Nipro Medical Corporation

K number K051828

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MEB 2005-12-08

MPS ACACIA MEDFLO ELASTOMERIC PUMP

Applicant Mps Acacia

K number K052451

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MEB 2005-09-09

I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)

Applicant I-Flow Corp.

K number K052117

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MEB 2005-07-01

SYMBIOS DISPOSABLE INFUSION PUMP KIT

Applicant Symbios Medical Products, LLC

K number K051474

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MEB 2005-04-14

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

Applicant Mckinley Medical, LLC

K number K050770

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MEB 2004-09-22

SMARTINFUSER PAINPUMP

Applicant Precise Medical Products

K number K042122

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MEB 2004-08-31

MULTI-DRIP INFUSION CATHETER

Applicant Advanced Infusion, Inc.

K number K042246

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MEB 2004-08-26

AUTOFUSER AMBULATORY INFUSION PUMP

Applicant Algos, LC

K number K041585

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MEB 2004-05-24

I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

Applicant I-Flow Corp.

K number K040337

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MEB 2004-04-07

DOSI-FUSER

Applicant Leventon, S.A.

K number K040752

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MEB 2003-10-07

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS

Applicant Mckinley, Inc.

K number K033039

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MEB 2003-07-15

B. BRAUN NERVE BLOCK CATHETER

Applicant B.Braun Medical, Inc.

K number K030830

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MEB 2002-12-20

HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO

Applicant I-Flow Corp.

K number K023883

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MEB 2002-12-09

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT

Applicant Mckinley Infuser

K number K023098

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MEB 2002-10-18

I-FLOW ELASTOMERIC PUMP WITH BOLUS

Applicant I-Flow Corp.

K number K023318

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MEB 2002-08-12

ALPHA INFUSION PUMP AND CATHETERS

Applicant Advanced Infusion, Inc.

K number K021964

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MEB 2002-05-17

PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719

Applicant Baxter Healthcare Corp

K number K021274

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MEB 2002-04-04

PAIN CARE 4200

Applicant Breg, Inc.

K number K020988

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MEB 2002-03-26

I-FLOW ELASTOMERIC PUMP

Applicant I-Flow Corp.

K number K020862

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MEB 2002-03-20

HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO

Applicant I-Flow Corp.

K number K020660

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MEB 2001-12-03

PAIN CARE 3200

Applicant Breg, Inc.

K number K013928

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MEB 2001-07-09

MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS

Applicant Mps Acacia

K number K011117

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MEB 2001-06-28

MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM

Applicant Baxter Healthcare Corp

K number K011317

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MEB 2001-06-05

PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

Applicant Science Incorporated

K number K010824

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MEB 2001-02-15

ACCUFUSER; ACCUFUSER PLUS

Applicant Help Technologies

K number K003915

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MEB 2001-01-12

MPS ACACIA PAIN KIT

Applicant Mps Acacia

K number K003476

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MEB 2000-09-19

PAIN CARE 3000

Applicant Breg, Inc.

K number K002073

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MEB 2000-09-07

P.O.P. PAIN KIT

Applicant Post Operative Pain Management

K number K001342

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MEB 2000-08-14

PAIN CARE 2000L

Applicant Breg, Inc.

K number K002321

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MEB 2000-05-09

GO MEDICAL BALLOON INFUSION SYSTEM

Applicant Go Medical Industries Pty. , Ltd.

K number K000263

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MEB 2000-02-09

AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10

Applicant Tandem Medical, Inc.

K number K993832

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MEB 2000-02-07

DISPOSABLE INFUSION PUMP KIT

Applicant Biomet, Inc.

K number K993972

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MEB 1999-10-27

ALPHA INFUSION PUMP

Applicant Advanced Infusion, Inc.

K number K992551

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MEB 1999-10-25

INTRAOP CATHETER

Applicant I-Flow Corp.

K number K991543

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MEB 1999-09-10

FREEDOM INFUSION SYSTEM

Applicant Novacon Corp.

K number K992015

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MEB 1999-06-30

MCKINLEY SP DISPOSABLE INFUSION PUMP

Applicant Mckinley, Inc.

K number K990461

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MEB 1999-06-03

AUTODOSE INFUSION SYSTEM

Applicant Tandem Medical, Inc.

K number K990889

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MEB 1999-03-04

NERVE BLOCK INFUSION KIT

Applicant I-Flow Corp.

K number K984502

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MEB 1999-02-24

PREPARE HOME INFUSION PUMP

Applicant Medical Infusion Technologies, Inc.

K number K983634

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MEB 1998-12-16

PAIN CARE 2000

Applicant Breg, Inc.

K number K983454

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MEB 1998-11-18

PAINBUSTER INFUSION KIT

Applicant I-Flow Corp.

K number K982946

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MEB 1998-09-30

OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP

Applicant Mckinley, Inc.

K number K982256

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MEB 1998-09-04

SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY

Applicant Baxter Healthcare Corp

K number K982102

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MEB 1998-05-28

PAINBUSTER INFUSION SYSTEM

Applicant I-Flow Corp.

K number K980558

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MEB 1998-02-20

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

Applicant Princeton Regulatory Assoc.

K number K972158

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MEB 1997-12-04

PERSONAL INFUSOR

Applicant Science Incorporated

K number K971362

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MEB 1997-08-15

MEDI-SIS SYRINGE INFUSION SYSTEM

Applicant I-Flow Corp.

K number K972173

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MEB 1997-07-15

ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE

Applicant Baxter Healthcare Corp

K number K971168

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MEB 1997-06-19

MICROJECT MODEL PCA-1

Applicant Microject, Inc.

K number K965222

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MEB 1996-10-04

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET

Applicant Solopak Medical Products, Inc.

K number K963355

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MEB 1996-10-04

SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET

Applicant Solopak Medical Products, Inc.

K number K962663

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MEB 1996-08-05

DIB INFUSOR-RA

Applicant Novacon Corp.

K number K960318

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MEB 1996-08-05

DIB INFUSOR

Applicant Novacon Corp.

K number K955849

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MEB 1996-02-08

BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET

Applicant I-Flow Corp.

K number K955727

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MEB 1995-09-29

TITAN 20 CC DRIVER

Applicant I-Flow Corp.

K number K954059

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MEB 1995-09-28

TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET

Applicant I-Flow Corp.

K number K953028

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MEB 1995-07-18

INFUSION PUMP

Applicant I-Flow Corp.

K number K941418

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MEB 1995-02-14

DIB INFUSORS

Applicant Novacon Corp.

K number K944665

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MEB 1994-11-03

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM

Applicant Baxter Healthcare Corp

K number K943664

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MEB 1994-09-02

DISPOSABLE, AMBULATORY, INFUSION PUMPS

Applicant Vlv Associates, Inc.

K number K940406

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MEB 1994-08-05

DIB INFUSOR

Applicant Novacon Corp.

K number K941766

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MEB 1994-06-10

MID-500

Applicant Block Medical, Inc.

K number K940117

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MEB 1994-02-25

DIB INFUSOR

Applicant Novacon Corp.

K number K930404

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MEB 1993-02-05

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE

Applicant Baxter Healthcare Corp

K number K922382

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MEB 1992-10-05

PRIME CADI-120

Applicant Prime Medical Products, Inc.

K number K914148

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MEB 1992-07-17

GENESIS(TM) INFUSION SYSTEM

Applicant Norman'S

K number K911636

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MEB 1992-03-26

IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD

Applicant Imed Corp.

K number K913658

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