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

Anaerobe Systems — Predicate Candidate Screening

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

25 daysmedian FDA review time

52 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days
K844383	KANAMYCIN 1000 MCG DIFFERENTIAL DISK	Anaerobe Systems	1985-01-04	52
K844382	VANCOMYCIN 5MCG DIFFERENTIAL DISK	Anaerobe Systems	1985-01-04	52
K844381	COLISTIN 10 MCG. DIFFERENTIAL DISK	Anaerobe Systems	1985-01-04	52
K844380	BILE DIFFERENTIAL DISK	Anaerobe Systems	1985-01-04	52
K841303	CAMPYLOBACTER THIOGLYCOLLATE MED	Anaerobe Systems	1984-04-17	18
K841142	LEVINE EOSIN METHYLENE BLUE AGAR	Anaerobe Systems	1984-04-05	20
K841218	CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR	Anaerobe Systems	1984-04-05	14
K841220	ANAEROBIC TRANSPORT MEDIUM	Anaerobe Systems	1984-04-04	13
K841221	BRAIN HEART INFUSION BROTH	Anaerobe Systems	1984-04-04	13
K841138	MUELLER HINTON AGAR W/BLOOD & COFACTOR	Anaerobe Systems	1984-04-04	19
K841219	SHOPPED MEAT CARBOHYDRATE	Anaerobe Systems	1984-04-04	13
K841222	BACTEROIDES BILE ESCULIN GAR	Anaerobe Systems	1984-04-04	13
K841137	MUELLER HINTON AGAR W/WO BLOOD	Anaerobe Systems	1984-03-26	10
K841139	COLUMBIA AGAR W/COLISTIN, NALADIXIC	Anaerobe Systems	1984-03-26	10
K841144	CHOCOLATE AGAR W/COFACTOR	Anaerobe Systems	1984-03-26	10
K841136	SABOURAUD DEXTROSE AGAR W/CHLORAMPHE	Anaerobe Systems	1984-03-26	10
K841143	COLUMBIA AGAR W/5% SHEEP BLOOD	Anaerobe Systems	1984-03-26	10
K841140	PHENYLETHYL ALCOHOL BLOOD AGAR	Anaerobe Systems	1984-03-26	10
K841135	MYCOSEL AGAR W/CHLORAMPHENICOL &	Anaerobe Systems	1984-03-26	10
K841141	MACCONKEY AGAR	Anaerobe Systems	1984-03-26	10
K841134	MANNITOL SALT AGAR	Anaerobe Systems	1984-03-26	10
K841129	HEKTOEN ENTERIC AGAR	Anaerobe Systems	1984-03-23	7
K841133	THAYER MARTIN MEDIUM	Anaerobe Systems	1984-03-23	7
K841132	EILE-ESCULIN AZIDE AGAR	Anaerobe Systems	1984-03-23	7
K841130	TRYPTICASE SOY AGAR W/5% SHEEP BLOOD	Anaerobe Systems	1984-03-23	7
K841131	XYLOSE LYSINE DESOXYCHOLATE AGAR	Anaerobe Systems	1984-03-23	7
K840030	REAGENTS	Anaerobe Systems	1984-03-02	57
K840029	STRIPS	Anaerobe Systems	1984-03-02	57
K840028	DISCS	Anaerobe Systems	1984-03-02	57
K840031	MICROBIAL DIFFERENTIATION	Anaerobe Systems	1984-03-02	57
K834357	ANA TRANS TUBE & SWABS STERILE PACK	Anaerobe Systems	1984-01-31	49
K791578	CAMPYLOBACTER SELECTIVE MEDIUM	Anaerobe Systems	1979-09-27	41
K791563	ANAEROBIC BRUCELLA LAKED BLOOD AGAR	Anaerobe Systems	1979-09-17	34
K791562	ANAEROBIC BRUCELLA BLOOD AGAR	Anaerobe Systems	1979-09-17	34
K791579	ANAEROBIC BRUCELLA BLOOD AGAR	Anaerobe Systems	1979-09-17	31
K790627	LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID	Anaerobe Systems	1979-05-01	33
K790625	PEPTONE-YEAST EXTRACT BROTH	Anaerobe Systems	1979-05-01	33
K790618	LOMBARD-DOWELL STARCH AGAR	Anaerobe Systems	1979-04-23	25
K790621	CHOPPED MEAT GLUCOSE MEDIUM	Anaerobe Systems	1979-04-23	25
K790620	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	Anaerobe Systems	1979-04-23	25
K790616	ENRICHED THIOGLYCOLLATE MEDIUM	Anaerobe Systems	1979-04-23	25
K790623	LOMBARD-DOWELL MILK AGAR	Anaerobe Systems	1979-04-23	25
K790617	CARBOHYDRATE FERMENTATION MEDIA	Anaerobe Systems	1979-04-23	25
K790628	LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR	Anaerobe Systems	1979-04-23	25
K790622	CHOPPED MEAT AGAR	Anaerobe Systems	1979-04-23	25
K790624	LOMBARD-DOWELL BROTH MEDIUM W/LACTATE	Anaerobe Systems	1979-04-23	25
K790619	LOMBARD-DOWELL BROTH MEDIUM	Anaerobe Systems	1979-04-23	25
K790626	LOMBARD-DOWELL GLUCOSE AGAR	Anaerobe Systems	1979-04-23	25
K781856	PLATE, LD PRESUMPTO	Anaerobe Systems	1978-11-22	16
K781604	CDC ANAEROBE BLOOD AGAR	Anaerobe Systems	1978-10-10	22

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