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

JSD — Predicate Candidate Screening

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

30 daysmedian FDA review time

51 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K883075	FASTIDIOUS INOCULUM BROTH	Baxter Healthcare Corp	1988-08-15	33	0
K880107	CAMPY BROTH	Hardy Media	1988-03-30	84	0
K873324	SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331	Lakewood Biochemical Co., Inc.	1987-10-02	45	0
K873218	BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802	Lakewood Biochemical Co., Inc.	1987-09-23	40	0
K871640	ALKALINE PEPTONE WATER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-05-13	16	0
K871447	TODD HEWITT W/CNA (LIM BROTH)	Remel Co.	1987-05-13	30	1
K870594	T9802 TSB W/6.5% NACL	Lakewood Biochemical Co., Inc.	1987-03-30	48	0
K853609	APL TRYPTIC SOY BROTH	Apl Medical Supplies	1985-09-12	14	0
K844547	TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE	bioMerieux, Inc.	1985-01-16	56	0
K841836	SELECTIVE CULTURE MED. TRICHOMONAS	Microline Scientific	1984-05-14	27	0
K840971	SELECTIVE CULTURE MEDIUM	Chatham Biological	1984-04-13	38	0
K841211	SELECTIVE BROTH	Smith River Biologicals	1984-04-05	24	0
K834013	SF BROTH	Micro Media Laboratories	1983-12-27	36	0
K834015	SELENITE BROTH	Micro Media Laboratories	1983-12-22	31	0
K833759	GROUP STREP BROTH T3472 LIM	Gibco Laboratories Life Technologies, Inc.	1983-12-16	51	0
K832310	ROGOSA BROTH	Oxoid U.S.A., Inc.	1983-09-01	49	0
K822330	BACTEC DILUTING FLUID	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-09-02	30	0
K822131	DERMATOPHYTE TEST MEDIUM	Granite Diagnostics, Inc.	1982-08-03	15	0
K820843	CULTURE MEDIA SELECTIVE BROTH	Blue Ridge Media Co.	1982-04-16	21	0
K820558	SELENITE BROTH	American Laboratory Supply, Inc.	1982-03-16	14	0
K812451	CAMPY THIOGLYCOLLATE (TUBE)	Granite Diagnostics, Inc.	1981-09-23	26	0
K811326	SABOURAUD LIQUID, BROTH MODIFIED	Acumedia Manufacturers, Inc.	1981-05-28	16	0
K791589	G N BROTH HAJNA	Isle Media and Sterile Products, Inc.	1979-09-17	34	0
K791481	LAURYL TRYPTOSE BROTH	Isle Media and Sterile Products, Inc.	1979-08-22	23	0
K791484	SELENITE BROTH	Isle Media and Sterile Products, Inc.	1979-08-22	23	0
K791471	SELENITE CYSTINE BROTH	Isle Media and Sterile Products, Inc.	1979-08-22	23	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