Atlas FDA

MLR

47 FDA 510(k) clearances · Product code

196 daysmedian time to decision
431 days90th percentile
47clearances measured

FDA profile

Official device name
Sterilizer, Chemical
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6860
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 202 · 2022: 188 · 2023: 140 · 2024: 44 · 2025: 47 · 2026: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STERRAD 100NX Sterilization System with ALLClear Technology (10104) (K252843)Advanced Sterilization Products, Inc.2026-04-15
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802)Advanced Sterilization Products, Inc.2025-04-14
LOWTEM Crystal 120 (K231893)Lowtem Co., Ltd.2024-09-18
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (K234082)Advanced Sterilization Products2024-07-05
SteroScope® Sterilization Technology System (K233762)Ideate Medical, Inc.2024-06-27
V-PRO maX 2 Low Temperature Sterilization System (K233065)Steris2023-10-20
V-PRO maX 2 Low Temperature Sterilization System (K223476)STERIS Corporation2023-08-07
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) (K231169)Plasmapp Co,., Ltd.2023-05-25
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015)Plasmapp Co,., Ltd.2023-05-09
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) (K220345)Plasmapp Co,., Ltd.2023-04-14
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (K222093)Steris2022-09-09
STERRAD NX with ALLClear Technology (K220404)Advanced Sterilization Products, Inc.2022-05-16
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (K212200)Plasmapp Co,., Ltd.2021-10-22
STERRAD 100NX Sterilizer with ALLClear Technology (K212174)Advanced Sterilization Products, Inc.2021-10-09
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (K190005)Sterilucent, Inc.2019-09-13
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems (K190917)STERIS Corporation2019-05-09
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 (K190103)STERIS Corporation2019-04-05
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K182568)STERIS Corporation2019-01-03
V-PRO maX 2 Low Temperature Sterilization System (K172754)STERIS Corporation2018-02-09
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 (K172319)STERIS Corporation2018-01-18
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 (K162413)STERIS Corporation2017-03-31
STERRAD NX Sterilizer (K162007)Advanced Sterilization Products2017-02-16
STERRAD® NX Sterilizer with ALLClear™ Technology (K160818)Advanced Sterilization Products2016-09-27
STERRAD 100NX Sterilizer with ALLClearTM Technology (K160903)Advanced Sterilization Products2016-09-26
V-PRO® 1 Plus and V-PRO® maX Low Temperature (K160433)STERIS Corporation2016-07-06
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K151725)Advanced Sterilization Products2016-01-13
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K142454)Advanced Sterilization Products2015-04-03
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (K140464)Sterilucent, Inc.2014-10-31
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM (K140498)STERIS Corporation2014-07-24
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K131120)STERIS Corporation2013-07-16
STERRAD(R) 100NX STERILIZER DUO CYCLE (K111377)Advanced Sterilization Products2012-09-13
AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM (K120632)STERIS Corporation2012-06-26
AMSCO V-PRO (K112813)Steris Corp2011-12-01
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K112760)STERIS Corporation2011-11-22
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS (K111810)STERIS Corporation2011-09-02
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM (K102394)STERIS Corporation2011-08-18
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K102330)STERIS Corporation2011-08-12
STERRAD 100NX STERILIZER EXPRESS CYCLE (K092622)Advanced Sterilization Products2011-03-04
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM (K083097)STERIS Corporation2009-08-03
STERRAD 100NX STERILIZER (K071385)Advanced Sterilization Products2007-11-29
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM (K062297)STERIS Corporation2007-10-04
STERRAD NX STERILIZER (K042116)Advanced Sterilization Products2005-04-22
STERRAD 200 STERILIZER (K030429)Advanced Sterilization Products2003-08-18
STERRAD 100S STERILIZER (K991999)Advanced Sterilization Products2000-06-15
STERRAD 50 STERILIZER (K981625)Advanced Sterilization Products1999-01-11
HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS (K943654)Mdt Biologic Co.1995-08-02
MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (K924380)Mdt Corp., Inc.1994-02-16

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Every clearance here is in the API, with alerts when new ones post.