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

JSO — Predicate Candidate Screening

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

114 daysmedian FDA review time

321 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190553	HardyCHROM CRE	Hardy Diagnostics	2019-04-29	55	1
K181092	CHROMID CARBA agar (CARB)	Biomerieux S.A.	2018-07-06	72	1
K171061	MRSASelect II	Bio-Rad	2017-12-28	262	0
K162620	Remel Spectra ESBL	Remel, Inc.	2017-05-01	223	0
K160512	HardyCHROM ESBL	Hardy Diagnostics	2016-11-15	265	0
K162076	chromID MRSA	bioMerieux, Inc.	2016-10-25	90	2
K151688	chromID MRSA	bioMerieux, Inc.	2016-03-11	262	0
K122187	VRESELECT CULTURE MEDIUM	Bio-Rad	2012-11-06	105	0
K103684	VRESELECT CULTURE MEDIUM	Bio-Rad	2011-10-21	308	0
K102922	HARDYCHROM MRSA	Hardy Diagnostics	2011-05-04	215	2
K100589	MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS	Bio-Rad	2010-10-29	241	0
K092407	REMEL SPECTRA MRSA	Remel, Inc.	2010-10-08	428	1
K092767	BBL CHROMAGAR MRSA II	Becton, Dickinson & CO	2010-08-20	345	0
K092819	REMEL SPECTRA VRE	Thermo Fisher Scientific	2010-07-15	304	0
K091025	CHROMID VRE AGAR, MODEL: REF 43 851	bioMerieux, Inc.	2010-03-02	326	1
K091024	CHROMID MRSA AGAR, MODEL: REF 43 841	bioMerieux, Inc.	2009-07-17	98	0
K081212	MRSASELECT - EXTENDED INCUBATION	Bio-Rad	2008-06-13	45	0
K073027	SPECTRA MRSA	Thermo Fisher Scientific	2008-02-28	125	0
K070361	MRSASELECT	Bio-Rad	2007-09-13	218	0
K042812	BBLCHROMAGAR MRSA	Becton, Dickinson & CO	2004-11-22	41	0
K972359	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	Remel, L.P.	1997-08-28	64	0
K964560	BHI W/VANCOMYCIN AGAR	Hardy Diagnostics	1997-01-15	63	1
K962744	HAEMOPHILUS TEST MEDIUM AGAR (HTM)	Prepared Media Laboratory, Inc.	1996-10-15	92	0
K952595	HAEMOPHILUS TEST MEDIUM (HTM)	Clinical Standards Laboratories, Inc.	1996-04-10	309	0
K951754	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST	Hardy Diagnostics	1995-10-16	182	0
K945569	GCII AGAR WITH ISOVITALX(R) ENRICHMENT	Becton Dickinson Microbiology Systems	1995-02-02	114	0
K944554	BRAIN HEART INFUSION AGAR	Carr-Scarborough Microbiologicals, Inc.	1994-10-04	18	0
K941444	BHI AGAR WITH VANCOMYCIN	Remel Co.	1994-09-19	179	0
K941443	SYNERGY QUAD	Remel Co.	1994-09-19	179	0
K932882	GC II AGAR WITH ISOVITALEX	Becton Dickinson Microbiology Systems	1993-09-24	102	0
K932879	G C II AGAR WITH SENSIVITALEX	Becton Dickinson Microbiology Systems	1993-09-21	99	0
K923892	SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA	Smith River Biologicals	1993-06-21	321	0
K903425	HAEMOPHILUS TEST MEDIUM (HTM) BROTH	Bd Becton Dickinson Vacutainer Systems Preanalytic	1990-08-22	22	0
K894216	HAEMOPHILUS TEST MEDIUM (HTM)AGAR	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-12-13	177	0
K894848	HAEMOPHILUS TEST MEDIUM (BROTH)	Regional Media Laboratories	1989-09-06	37	0
K892928	HAEMOPHILUS TEST MEDIUM (AGAR)	Remel Co.	1989-06-13	53	3
K881568	WILKENS CHALGREN BROTH	Acumedia Manufacturers, Inc.	1988-04-18	7	0
K881567	WILKENS CHALGREN AGAR	Acumedia Manufacturers, Inc.	1988-04-18	7	0
K811513	WILKINS-CHALGREN ANAEROBE AGAR	Oxoid U.S.A., Inc.	1981-06-18	21	0
K770441	GAR, COLUMBIA, W/5% HORSE BLOOD	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-03-10	3	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