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

JSC — Predicate Candidate Screening

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

25 daysmedian FDA review time

47 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K850143	SPORDEX CULTURE MEDIA	American Sterilizer Co.	1985-03-05	50	0
K842852	BRAIN HEART INFUSION BROTH	Anarobe Systems	1984-08-03	14	0
K842849	TRYPTICASE SOY BROTH	Anarobe Systems	1984-08-03	14	0
K841221	BRAIN HEART INFUSION BROTH	Anaerobe Systems	1984-04-04	13	0
K841219	SHOPPED MEAT CARBOHYDRATE	Anaerobe Systems	1984-04-04	13	0
K833300	SABOURAUD BHI AGAR	Acumedia Manufacturers, Inc.	1983-11-07	46	0
K832620	TRYPTIC SOY BROTH MEDIA	Carroll Biological Corp.	1983-09-12	66	0
K832569	INFUSION BROTH	Acumedia Manufacturers, Inc.	1983-09-12	41	0
K832570	EXTRACT BROTH	Acumedia Manufacturers, Inc.	1983-09-12	41	0
K832619	THIOGLYCOLLATE MEDIUM	Carroll Biological Corp.	1983-09-12	66	0
K830437	CHS	Dms Laboratories	1983-03-17	36	0
K822665	WILKINS-CHALGREN ANAEROBE BROTH	Oxoid U.S.A., Inc.	1982-09-21	18	0
K822487	MINITEK GRAM-POSITIVE BROTH & SET AND	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-09-21	35	0
K821864	THIOGLYCOLLATE MED. W/VITAMIN K-1	Granite Diagnostics, Inc.	1982-07-13	19	0
K821597	BRAIN HEART INFUSION	Hardy Media	1982-07-08	49	0
K821610	THIOGLYCOLATE WITHOUT INDICATOR	Hardy Media	1982-07-06	39	0
K821598	FLUID THIOGLYCOLLATE BROTH	Hardy Media	1982-07-06	47	0
K821601	TRYPTIC SOY AGAR	Hardy Media	1982-07-06	39	0
K821600	TRYPTIC SOY BROTH	Hardy Media	1982-07-06	47	0
K820840	CULTURE MEDIA, GENERAL NUTRIENT BROTH	Blue Ridge Media Co.	1982-04-16	21	0
K820795	#4006 TSB-TUBED MEDIA	Biomedica, Inc.	1982-04-08	16	0
K820796	#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE	Biomedica, Inc.	1982-04-08	16	0
K813611	CHE	Dms Laboratories	1982-02-04	37	0
K813615	CHL	Dms Laboratories	1982-02-04	37	0
K812335	TRYPTICASE SOY BROTH BLOOD CULTURE BOTT	Fisher Scientific Co., LLC	1981-09-09	22	0
K811602	TRYPTIC SOY BROTH	Micro Media Laboratories	1981-06-25	17	0
K811323	NUTRIENT BROTH	Acumedia Manufacturers, Inc.	1981-05-28	16	0
K811132	EUGON BROTH	Acumedia Manufacturers, Inc.	1981-05-05	11	0
K811056	BRAIN HEART INFUSION	Acumedia Manufacturers, Inc.	1981-04-29	13	0
K803026	PEPTONE YEAST EXTRACT GLUCOSE BROTH	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-12-22	26	0
K802408	E-VAC BLOOD CULTURE SYSTEM	Pfizer Pharmaceuticals	1980-10-23	20	0
K800429	TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%	Abbott Laboratories	1980-03-19	22	0
K800426	TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST	Abbott Laboratories	1980-03-19	22	0
K800428	TRYPTIC SOY BROTH W/CYSTEINE AND	Abbott Laboratories	1980-03-19	22	0
K800427	TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT	Abbott Laboratories	1980-03-19	22	0
K792056	FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT	Fisher Scientific Co., LLC	1979-11-16	32	0
K791623	TRYPTIC SOY BROTH	American Laboratory Supply, Inc.	1979-09-27	37	0
K791478	FLUID THIOGLYCOLLATE MEDIUM	Isle Media and Sterile Products, Inc.	1979-09-04	36	0
K791292	BRAIN HEART INFUSION WITH AGAR BROTH	Isle Media and Sterile Products, Inc.	1979-07-17	22	0
K791194	BRAIN HEART INFUSION BROTH	Isle Media and Sterile Products, Inc.	1979-07-17	22	0
K791171	TRYPTIC SOY BROTH	Isle Media and Sterile Products, Inc.	1979-07-17	22	0
K791193	NUTRIENT BROTH	Isle Media and Sterile Products, Inc.	1979-07-17	22	0
K791291	BRAIN HEART INFUSION WITH BROTH	Isle Media and Sterile Products, Inc.	1979-07-17	22	0
K790687	BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2	Gibco Laboratories Life Technologies, Inc.	1979-05-03	23	1
K790625	PEPTONE-YEAST EXTRACT BROTH	Anaerobe Systems	1979-05-01	33	0
K790614	LOMBARD-DOWELL MEDIUM WITH GLUCOSE	Anerobe Systems	1979-04-23	25	0
K790620	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	Anaerobe Systems	1979-04-23	25	0
K790616	ENRICHED THIOGLYCOLLATE MEDIUM	Anaerobe Systems	1979-04-23	25	0
K790613	CHOPPED MEAT GLOCOSE STARCH MEDIUM	Anerobe Systems	1979-04-23	25	0
K790615	CHOPPED MEAT MEDIUM	Anerobe Systems	1979-04-23	25	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