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Sterilizer, Chemical

FDA product code MLR · 44 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6860
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1994-02-16 – 2026-04-15

MLR 2026-04-15

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Applicant Advanced Sterilization Products, Inc.

K number K252843

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MLR 2025-04-14

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

Applicant Advanced Sterilization Products, Inc.

K number K250802

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MLR 2024-09-18

LOWTEM Crystal 120

Applicant Lowtem Co., Ltd.

K number K231893

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MLR 2024-07-05

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

Applicant Advanced Sterilization Products

K number K234082

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MLR 2024-06-27

SteroScope® Sterilization Technology System

Applicant Ideate Medical, Inc.

K number K233762

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MLR 2023-10-20

V-PRO maX 2 Low Temperature Sterilization System

Applicant Steris

K number K233065

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MLR 2023-08-07

V-PRO maX 2 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K223476

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MLR 2023-05-25

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K number K231169

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MLR 2023-05-09

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

Applicant Plasmapp Co,., Ltd.

K number K223015

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MLR 2023-04-14

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K number K220345

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MLR 2022-09-09

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

Applicant Steris

K number K222093

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MLR 2022-05-16

STERRAD NX with ALLClear Technology

Applicant Advanced Sterilization Products, Inc.

K number K220404

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MLR 2021-10-22

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

Applicant Plasmapp Co,., Ltd.

K number K212200

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MLR 2021-10-09

STERRAD 100NX Sterilizer with ALLClear Technology

Applicant Advanced Sterilization Products, Inc.

K number K212174

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MLR 2019-09-13

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

Applicant Sterilucent, Inc.

K number K190005

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MLR 2019-05-09

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

Applicant STERIS Corporation

K number K190917

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MLR 2019-04-05

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K190103

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MLR 2019-01-03

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K182568

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MLR 2018-02-09

V-PRO maX 2 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K172754

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MLR 2018-01-18

AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K172319

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MLR 2017-03-31

AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K number K162413

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MLR 2017-02-16

STERRAD NX Sterilizer

Applicant Advanced Sterilization Products

K number K162007

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MLR 2016-09-27

STERRAD® NX Sterilizer with ALLClear™ Technology

Applicant Advanced Sterilization Products

K number K160818

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MLR 2016-09-26

STERRAD 100NX Sterilizer with ALLClearTM Technology

Applicant Advanced Sterilization Products

K number K160903

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MLR 2016-07-06

V-PRO® 1 Plus and V-PRO® maX Low Temperature

Applicant STERIS Corporation

K number K160433

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MLR 2016-01-13

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

Applicant Advanced Sterilization Products

K number K151725

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MLR 2013-07-16

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K131120

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MLR 2012-09-13

STERRAD(R) 100NX STERILIZER DUO CYCLE

Applicant Advanced Sterilization Products

K number K111377

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MLR 2012-06-26

AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K120632

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MLR 2011-12-01

AMSCO V-PRO

Applicant Steris Corp

K number K112813

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MLR 2011-11-22

AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K112760

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MLR 2011-09-02

AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS

Applicant STERIS Corporation

K number K111810

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MLR 2011-08-18

AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K102394

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MLR 2011-08-12

AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K102330

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MLR 2011-03-04

STERRAD 100NX STERILIZER EXPRESS CYCLE

Applicant Advanced Sterilization Products

K number K092622

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MLR 2009-08-03

AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K083097

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MLR 2007-11-29

STERRAD 100NX STERILIZER

Applicant Advanced Sterilization Products

K number K071385

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MLR 2007-10-04

VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM

Applicant STERIS Corporation

K number K062297

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MLR 2005-04-22

STERRAD NX STERILIZER

Applicant Advanced Sterilization Products

K number K042116

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MLR 2003-08-18

STERRAD 200 STERILIZER

Applicant Advanced Sterilization Products

K number K030429

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MLR 2000-06-15

STERRAD 100S STERILIZER

Applicant Advanced Sterilization Products

K number K991999

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MLR 1999-01-11

STERRAD 50 STERILIZER

Applicant Advanced Sterilization Products

K number K981625

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MLR 1995-08-02

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS

Applicant Mdt Biologic Co.

K number K943654

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MLR 1994-02-16

MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE

Applicant Mdt Corp., Inc.

K number K924380

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