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

MSY — Predicate Candidate Screening

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

98 daysmedian FDA review time

349 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K243898	Chlorine Sentinel II	Nelson Environmental Technologies, Inc.	2025-04-11	113
K222167	E-Z Chek Chlorine Residual Test Strips (K100-0101B)	Reprocessing Products Corporation (Rpc)	2022-10-18	89
K193169	Nelson Sentinel Series Basic Chlorine Sentinel	Nelson Environmental Technologies, Inc.	2020-10-29	349
K132344	E-Z CHECK OZONE TEST STRIPS	Reprocessing Products Corporation (Rpc)	2014-02-25	211
K090338	ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE	Reprocessing Products Corp	2009-05-08	87
K080712	SERIM HISENSE ULTRA 0.1, PART NUMBER 5167	Serim Research Corp.	2008-05-06	54
K002011	GLUTARTEST 1 REAGENT STRIP	Integrated Biomedical Technology, Inc.	2001-01-22	203
K001194	STERICHEK TOTAL CHLORINE REAGENT STRIPS	Environmental Test Systems, Inc.	2000-07-11	90
K994226	STERICHEK TOTAL CHLORINE REAGENT STRIPS	Environmental Test Systems, Inc.	2000-03-22	98
K983997	STERICHEK TOTAL CHLORINE TEST KIT	Environmental Test Systems, Inc.	1999-04-02	143
K974064	MICRO X RESIDUAL TEST STRIPS	Reprocessing Products Corp	1998-12-07	406
K980164	STERICHEK PERACETIC ACID REAGENT STRIPS	Environmental Test Systems, Inc.	1998-04-16	90
K971598	STERICHEK CHLORINE REAGENT STRIPS	Environmental Test Systems, Inc.	1997-07-18	78

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