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

Oxoid U.S.A., Inc. — Predicate Candidate Screening

93 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

33 daysmedian FDA review time

93 days90th percentile

93clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K891593	LISTERIA SELECTIVE ENRICHMENT MEDIUM	Oxoid U.S.A., Inc.	1989-06-09	81	0
K884026	ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT	Oxoid U.S.A., Inc.	1989-02-03	133	0
K884208	LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)	Oxoid U.S.A., Inc.	1988-10-25	19	0
K874303	STAPHYLASE TEST	Oxoid U.S.A., Inc.	1987-11-06	17	0
K872956	SORBITOL MACCONKEY AGAR NO. 3 CM 813	Oxoid U.S.A., Inc.	1987-08-10	12	0
K872135	MCBRIDE MEDIUM CM 819	Oxoid U.S.A., Inc.	1987-06-15	12	0
K870945	RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122	Oxoid U.S.A., Inc.	1987-06-10	93	0
K862946	OXOID SIGNAL BLOOD CULTURE SYSTEM	Oxoid U.S.A., Inc.	1986-11-05	92	0
K855235	DIAGNOSTIC REAGENT PET-RPLA	Oxoid U.S.A., Inc.	1986-11-04	308	0
K855233	DIAGNOSTIC REAGENT SET-RPLA	Oxoid U.S.A., Inc.	1986-11-04	308	0
K855236	DIAGNOSTIC REAGENT TST-RPLA	Oxoid U.S.A., Inc.	1986-11-04	308	0
K855234	DIAGNOSTIC REAGENT VET-RPLA	Oxoid U.S.A., Inc.	1986-11-04	308	0
K854929	OXOID STREPTOCOCAL GROUPING KIT	Oxoid U.S.A., Inc.	1986-03-11	91	0
K860153	OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS	Oxoid U.S.A., Inc.	1986-03-04	48	5
K850832	CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ	Oxoid U.S.A., Inc.	1985-03-29	42	0
K850658	CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE	Oxoid U.S.A., Inc.	1985-03-20	33	0
K844887	IDENTIFICATION STICKS OXIDASE	Oxoid U.S.A., Inc.	1985-02-25	70	0
K841659	DRIGALSKI LITMUS LACTOSE AGAR	Oxoid U.S.A., Inc.	1984-06-07	45	0
K841662	MAXIMUM RECOVERY DILUENT	Oxoid U.S.A., Inc.	1984-06-07	45	0
K841660	SELENITE CYSTINE BROTH BASE	Oxoid U.S.A., Inc.	1984-05-14	21	0
K841661	SYNTHETIC BROTH A.O.A.C.	Oxoid U.S.A., Inc.	1984-05-11	18	0
K841658	KF STREPTOCOCCUS AGAR	Oxoid U.S.A., Inc.	1984-05-11	18	0
K840330	PRESTON CAMPYLOBACTER SELECTIVE SUPP	Oxoid U.S.A., Inc.	1984-05-11	107	0
K840332	CAMPYLOBACTER AGAR BASE	Oxoid U.S.A., Inc.	1984-05-11	107	0
K840333	LEGIONELLA BMPA SELECTIVE SUPPLE	Oxoid U.S.A., Inc.	1984-05-11	107	0
K840331	LEGIONELLA MWY SELECTIVE SUPPLEMENT	Oxoid U.S.A., Inc.	1984-05-11	107	0
K833888	PENASE	Oxoid U.S.A., Inc.	1984-01-03	55	0
K833887	BRUCELLA BROTH	Oxoid U.S.A., Inc.	1983-12-12	33	0
K833886	BRUCELLA AGAR	Oxoid U.S.A., Inc.	1983-12-12	33	0
K832310	ROGOSA BROTH	Oxoid U.S.A., Inc.	1983-09-01	49	0
K832307	ONPG DISCS	Oxoid U.S.A., Inc.	1983-08-26	43	0
K832306	BILE AESCULIN DISCS	Oxoid U.S.A., Inc.	1983-08-24	41	0
K832305	SPS DISCS	Oxoid U.S.A., Inc.	1983-08-24	41	0
K831469	LEGIONELLA CYE AGAR BASE & BCYE SUPPL	Oxoid U.S.A., Inc.	1983-06-08	33	4
K830939	THYMINE/THYMIDINE DISCS DDG	Oxoid U.S.A., Inc.	1983-04-13	20	0
K830364	NEISSERIA IDENTIFICATION DISCS	Oxoid U.S.A., Inc.	1983-03-08	32	0
K822661	RAPID REAGIN CARD TEST	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822659	YERSINIA AGAR BASE & SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822663	FEBRILE ANTIGEN KIT	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822660	VOGEL JOHNSON AGAR	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822662	REAGIN ANTIGEN SUSPENSION	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822665	WILKINS-CHALGREN ANAEROBE BROTH	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822664	PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822458	YEAST AUTOLYXATE SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-14	29	0
K822460	LCAT ANTIBIOTIC SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-14	29	0
K822459	VCAT ANTIBIOTIC SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-14	29	0
K822461	N-S ANAEROBE SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-14	29	0
K822462	G-N ANAEROBE SUPPLEMENT	Oxoid U.S.A., Inc.	1982-09-14	29	0
K820010	GAS GENERATING KIT, CO2	Oxoid U.S.A., Inc.	1982-01-28	23	0
K813509	METRONIDAZOLE DIAGNOSTIC DISCS	Oxoid U.S.A., Inc.	1981-12-31	16	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