Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MLR — Predicate Candidate Screening

47 FDA 510(k) clearances under this product code; the 50 most recent screened below.

196 daysmedian FDA review time

431 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252843	STERRAD 100NX Sterilization System with ALLClear Technology	Advanced Sterilization Products, Inc.	2026-04-15	219	0
K250802	STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)	Advanced Sterilization Products, Inc.	2025-04-14	31	0
K231893	LOWTEM Crystal 120	Lowtem Co., Ltd.	2024-09-18	448	0
K234082	STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTR	Advanced Sterilization Products	2024-07-05	196	0
K233762	SteroScope® Sterilization Technology System	Ideate Medical, Inc.	2024-06-27	216	0
K233065	V-PRO maX 2 Low Temperature Sterilization System	Steris	2023-10-20	24	0
K223476	V-PRO maX 2 Low Temperature Sterilization System	STERIS Corporation	2023-08-07	262	0
K231169	STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll	Plasmapp Co,., Ltd.	2023-05-25	30	0
K223015	STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus casset	Plasmapp Co,., Ltd.	2023-05-09	222	0
K220345	STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek	Plasmapp Co,., Ltd.	2023-04-14	431	0
K222093	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX	Steris	2022-09-09	56	0
K220404	STERRAD NX with ALLClear Technology	Advanced Sterilization Products, Inc.	2022-05-16	91	0
K212200	STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette	Plasmapp Co,., Ltd.	2021-10-22	100	0
K212174	STERRAD 100NX Sterilizer with ALLClear Technology	Advanced Sterilization Products, Inc.	2021-10-09	89	0
K190005	Sterilucent HC 80TT Hydrogen Peroxide Sterilizer	Sterilucent, Inc.	2019-09-13	254	0
K190917	V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Lo	STERIS Corporation	2019-05-09	30	0
K190103	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX	STERIS Corporation	2019-04-05	73	0
K182568	V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low	STERIS Corporation	2019-01-03	107	0
K172754	V-PRO maX 2 Low Temperature Sterilization System	STERIS Corporation	2018-02-09	150	0
K172319	AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-	STERIS Corporation	2018-01-18	170	0
K162413	AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-	STERIS Corporation	2017-03-31	214	1
K162007	STERRAD NX Sterilizer	Advanced Sterilization Products	2017-02-16	211	0
K160818	STERRAD® NX Sterilizer with ALLClear™ Technology	Advanced Sterilization Products	2016-09-27	187	0
K160903	STERRAD 100NX Sterilizer with ALLClearTM Technology	Advanced Sterilization Products	2016-09-26	178	0
K160433	V-PRO® 1 Plus and V-PRO® maX Low Temperature	STERIS Corporation	2016-07-06	141	0
K151725	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	Advanced Sterilization Products	2016-01-13	201	1
K142454	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	Advanced Sterilization Products	2015-04-03	213	2
K140464	STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER	Sterilucent, Inc.	2014-10-31	249	0
K140498	V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2014-07-24	147	0
K131120	AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE S	STERIS Corporation	2013-07-16	85	0
K111377	STERRAD(R) 100NX STERILIZER DUO CYCLE	Advanced Sterilization Products	2012-09-13	486	1
K120632	AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2012-06-26	117	0
K112813	AMSCO V-PRO	Steris Corp	2011-12-01	65	0
K112760	AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2011-11-22	61	0
K111810	AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION	STERIS Corporation	2011-09-02	67	0
K102394	AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-	STERIS Corporation	2011-08-18	360	0
K102330	AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2011-08-12	360	0
K092622	STERRAD 100NX STERILIZER EXPRESS CYCLE	Advanced Sterilization Products	2011-03-04	555	0
K083097	AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2009-08-03	290	1
K071385	STERRAD 100NX STERILIZER	Advanced Sterilization Products	2007-11-29	195	5
K062297	VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	2007-10-04	423	1
K042116	STERRAD NX STERILIZER	Advanced Sterilization Products	2005-04-22	260	10
K030429	STERRAD 200 STERILIZER	Advanced Sterilization Products	2003-08-18	189	8
K991999	STERRAD 100S STERILIZER	Advanced Sterilization Products	2000-06-15	367	6
K981625	STERRAD 50 STERILIZER	Advanced Sterilization Products	1999-01-11	249	5
K943654	HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS	Mdt Biologic Co.	1995-08-02	370	0
K924380	MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE	Mdt Corp., Inc.	1994-02-16	534	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda