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

MED — Predicate Candidate Screening

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

175 daysmedian FDA review time

637 days90th percentile

64clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251666	SYSTEM 1E Liquid Chemical Sterilant Processing System, Model	STERIS Corporation	2026-04-08	313	0
K232914	SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500	STERIS Corporation	2023-10-03	14	0
K230582	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, M	STERIS Corporation	2023-03-28	26	0
K222615	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE	STERIS Corporation	2022-09-28	29	0
K211607	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE	STERIS Corporation	2021-09-07	105	0
K210737	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE	STERIS Corporation	2021-05-12	62	0
K192929	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE	STERIS Corporation	2019-12-10	54	0
K191343	SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Mo	STERIS Corporation	2019-09-05	108	0
K190104	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTE	Steris Corporations	2019-03-22	59	0
K182827	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, M	STERIS Corporation	2019-01-31	118	0
K180342	SYSTEM 1E Liquid Chemical Sterilant Processing System	Steris Corporations	2018-04-04	56	0
K173256	System 1 endo Liquid Chemical Sterilant Processing System	STERIS Corporation	2018-03-02	143	0
K170956	SYSTEM 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	2017-09-22	175	0
K161683	SYSTEM 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	2016-08-05	49	0
K140703	OPA 30 SOLUTION	Ciden Technologies, LLC	2014-08-19	152	0
K131078	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	STERIS Corporation	2013-07-05	79	1
K120306	RAPICIDE OPA-28	Minntech Corp.	2012-09-27	239	0
K113520	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	STERIS Corporation	2012-02-21	84	2
K113015	ALDAHOL V HIGH LEVEL DISINFECTANT	Microchem Laboratories, Inc.	2012-01-30	111	0
K102462	SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM	STERIS Corporation	2010-09-21	25	5
K101409	SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM	STERIS Corporation	2010-08-02	75	4
K091022	MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT	STERIS Corporation	2010-04-12	368	0
K090036	SYSTEM 1.5 STERILE PROCESSING SYSTEM	STERIS Corporation	2010-04-05	454	6
K091890	EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT	Healthpoint, Ltd.	2010-03-24	274	0
K091210	ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT	Best Sanitizers, Inc.	2010-02-05	287	1
K080420	RESERT XL HLD HIGH LEVEL DISINFECTANT	STERIS Corporation	2008-09-02	200	1
K070627	OPACIDEN SOLUTION	Ciden Technologies, LLC	2007-08-02	149	0
K063159	STERILOX LIQUID CHEMICAL STERILANT SYSTEM	Puricore, Inc.	2007-04-02	167	0
K061356	POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND	Advanced Infusion, Inc.	2006-07-03	49	0
K060618	CIDEX ACTIVATED DIALDEHYDE SOLUTION	Johnson & Johnson Co.	2006-04-12	35	1
K041984	ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT	Best Sanitizers, Inc.	2005-05-11	292	0
K041360	ALDAHOL III HIGH-LEVEL DISINFECTANT	Healthpoint, Ltd.	2005-05-05	349	0
K032959	CIDEX OPA CONCENTRATE	Advanced Sterilization Products	2005-04-04	559	0
K033381	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE W	Discus Dental, Inc.	2004-01-27	97	0
K012889	BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT	Pascal Co., Inc.	2003-05-27	637	1
K030004	0.55% ORTH-PHTHALALDEHYDE SOLUTION	Advanced Sterilization Products	2003-02-27	56	2
K013280	STERILOX LIQUID CHEMICAL STERILANT SYSTEM	Sterilox Technologies, Inc.	2002-09-18	351	0
K003087	MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLU	Sporicidin Intl.	2000-11-07	41	0
K002401	CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)	Advanced Sterilization Products	2000-08-29	22	1
K993042	MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT	Medivators, Inc.	2000-08-17	342	0
K001381	CIDEX OPA SOLUTION	Advanced Sterilization Products	2000-05-17	15	0
K991487	CIDEX OPA SOLUTION	Advanced Sterilization Products	1999-10-08	163	0
K972708	ENDO-SPOR PLUS / HYPROCIDE	Cottrell, Ltd.	1999-09-13	784	0
K984270	VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS,	Roger L. Goodman, D.D.S., P.C.	1999-05-20	171	0
K990703	SPOROX II STERILIZING & DISINFECTING SOLUTION	Reckitt Benckiser, Inc.	1999-03-30	26	0
K983194	SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)	Sporicidin Intl.	1999-03-05	175	0
K974188	CETYLCIDE-G	Kellerandheckman	1998-09-10	307	0
K974062	MEDSCI 3% GLUTARALDEHYDE	Medsci, Inc.	1998-09-02	310	0
K962959	PERACIDIN DIALYZER REPROCESSING CONCENTRATE	Hdc Medical, Inc.	1998-06-05	675	0
K970726	VAPOCIDE	Cottrell, Ltd.	1998-05-18	444	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