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

JSI — Predicate Candidate Screening

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

23 daysmedian FDA review time

67 days90th percentile

285clearances measured

K-number	Device	Applicant	Decided	Review days
K070691	BBL CHROMAGAR 0157	Becton, Dickinson & CO	2007-11-20	252
K974428	DIPSTREAK	Novamed , Ltd.	1998-07-30	248
K891593	LISTERIA SELECTIVE ENRICHMENT MEDIUM	Oxoid U.S.A., Inc.	1989-06-09	81
K890199	DENTOCULT SM-STRIP MUTANS	Orion Corp.	1989-03-02	43
K882182	SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326	Lakewood Biochemical Co., Inc.	1988-06-06	13
K881556	TRICHOMONAS BROTH	Acumedia Manufacturers, Inc.	1988-04-18	10
K881572	XL AGAR BASE	Acumedia Manufacturers, Inc.	1988-04-18	7
K881576	SELENITE BROTH	Acumedia Manufacturers, Inc.	1988-04-18	7
K881577	MODIFIED SELECTIVE STREPTOCOCCUS AGAR	Acumedia Manufacturers, Inc.	1988-04-18	7
K881575	SELECTIVE STREPTOCOCCUS AGAR	Acumedia Manufacturers, Inc.	1988-04-18	7
K881555	TINSDALE AGAR BASE	Acumedia Manufacturers, Inc.	1988-04-18	10
K880125	LOWENSTEIN-JENSEN, SELECTIVE	Hardy Media	1988-03-31	85
K880108	CORN MEAL W/POLYSORBATE 80	Hardy Media	1988-03-30	84
K880132	DERMATOPHYTE TEST MEDIUM	Hardy Media	1988-03-30	84
K880130	ATS MEDIA	Hardy Media	1988-03-30	84
K873259	SPECIALTY MEDIA	Central Media	1987-11-06	87
K874344	QUAD PLATE (4 DIFFERENT MEDIA)	Lakewood Biochemical Co., Inc.	1987-11-06	17
K873260	CORYNEBACTERIA ISOLATION MEDIA	Central Media	1987-11-06	87
K873258	STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA	Central Media	1987-11-06	87
K873269	MYCOLOGICAL MEDIA	Central Media	1987-11-04	85
K873264	MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS	Central Media	1987-10-28	78
K873262	DIFFERENTIAL MEDIA	Central Media	1987-10-28	78
K873261	ENTERIC ISOLATION MEDIA	Central Media	1987-10-28	78
K873265	MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION	Central Media	1987-10-28	78
K873481	HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873329	HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330	Lakewood Biochemical Co., Inc.	1987-10-02	43
K873227	MANNITOL SALT AGAR (MSA) PRODUCT #P1706	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873223	MACCONKEY AGAR - PRODUCT #P1606	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873225	EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873228	LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873226	XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601	Lakewood Biochemical Co., Inc.	1987-09-23	40
K872301	DENTOCULT-SM CULTURE-PADDLE	Orion Corp.	1987-09-11	88
K873055	MACCONKEY AGAR - PRODUCT #P1606	Lakewood Biochemical Co., Inc.	1987-08-24	20
K872675	IAFP MANNITOL NACL	I.A.F. Production, Inc.	1987-08-11	35
K872672	IAFP BILE ESCULIN AZIDE AGAR	I.A.F. Production, Inc.	1987-08-11	35
K872683	IAFP BILE ESCULIN AGAR	I.A.F. Production, Inc.	1987-08-11	35
K872682	IAFP S.S. AGAR	I.A.F. Production, Inc.	1987-08-11	35
K872669	IAFP X.L.D. AGAR	I.A.F. Production, Inc.	1987-08-11	35
K872956	SORBITOL MACCONKEY AGAR NO. 3 CM 813	Oxoid U.S.A., Inc.	1987-08-10	12
K872188	MACCONKEY W/SORBITOL	Remel Co.	1987-06-24	16
K872058	ORICULT-N CULTURE-PADDLE	Orion Corp.	1987-06-10	13
K870643	POTATO DEXTROSE AGAR	Hardy Media	1987-04-14	60
K870640	CETRIMIDE SELECTIVE AGAR	Hardy Media	1987-04-14	60
K870644	BRILLIANT GREEN AGAR	Hardy Media	1987-04-14	60
K870638	BACTEROIDES BILE ESCULIN AGAR	Hardy Media	1987-04-14	60
K870648	STAPHYLOCOCCUS 110 AGAR	Hardy Media	1987-04-14	60
K871088	ANAEROBIC LKV BLOOD AGAR	bioMerieux, Inc.	1987-04-03	16
K871094	BRILLIANT GREEN AGAR	bioMerieux, Inc.	1987-04-03	16
K864242	HEKTOEN ENTERIC AGAR	Mds Laboratories, Inc.	1987-03-31	154
K864243	MACCONKEY AGAR	Mds Laboratories, Inc.	1987-03-31	154

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