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

Oxoid , Ltd. — Predicate Candidate Screening

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

60 daysmedian FDA review time

184 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K070262	ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2007-03-14	47	1
K060286	TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2006-03-17	42	1
K042157	DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2004-09-14	35	0
K011710	OXOID PBP2 1 LATEX AGGLUTINATION TEST	Oxoid , Ltd.	2002-04-02	302	0
K012588	OXOID PYLORI TEST KIT, MODEL DR0130M	Oxoid , Ltd.	2001-12-10	122	0
K010536	MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2001-04-24	60	0
K010537	LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2001-04-24	60	0
K000930	GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	2000-05-22	61	0
K000928	QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST	Oxoid , Ltd.	2000-05-15	54	0
K993401	DRYSPOT E.COLI 0157 KIT	Oxoid , Ltd.	2000-02-28	143	0
K984513	TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1999-04-02	105	0
K984608	GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1999-03-09	71	0
K982634	DRYSPOT INFECTIOUS MONONUCLEOSIS KIT	Oxoid , Ltd.	1999-01-28	184	0
K984036	NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1999-01-13	62	0
K983718	MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-12-11	51	1
K982526	SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K982524	AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TES	Oxoid , Ltd.	1998-09-09	51	0
K982528	NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K982517	CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K982523	SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K982669	OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	40	0
K982520	CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K982519	LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-09-09	51	0
K971636	RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-01-28	271	0
K974394	ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1998-01-14	55	0
K971637	COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DIS	Oxoid , Ltd.	1997-12-23	235	0
K973479	CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-12-01	77	0
K973488	LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-10-10	25	0
K973489	LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-10-10	25	0
K973487	CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-10-06	21	1
K972030	STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS	Oxoid , Ltd.	1997-09-08	98	1
K971638	CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-08-20	110	0
K971632	TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TES	Oxoid , Ltd.	1997-08-13	103	0
K971635	AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-07-03	62	0
K971633	PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DI	Oxoid , Ltd.	1997-07-03	62	0
K971631	CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC	Oxoid , Ltd.	1997-07-03	62	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