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

JSF — Predicate Candidate Screening

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

35 daysmedian FDA review time

84 days90th percentile

87clearances measured

K-number	Device	Applicant	Decided	Review days
K880946	NUTRIENT GELATIN - PRODUCT NUMBER T2860	Lakewood Biochemical Co., Inc.	1988-04-01	25
K880126	LAURYL TRYPTOSE BROTH	Hardy Media	1988-03-31	85
K880120	MOELLERS DECARBOXYLASE, LYSINE	Hardy Media	1988-03-31	85
K880119	MOELLERS DECARBOXYLASE, ONITHINE	Hardy Media	1988-03-31	85
K880112	CYSTINE TRYPTIC MEDIUM W/ MALTOSE	Hardy Media	1988-03-30	84
K880113	CYSTINE TRYPTIC MEDIUM W/LACTOSE	Hardy Media	1988-03-30	84
K880118	MOELLOERS DECARBOXYLASE, ARGININE	Hardy Media	1988-03-30	84
K880110	CYSTINE TRYPTIC MEDIUM W/DEXTROSE	Hardy Media	1988-03-30	84
K880135	NITRATE BROTH	Hardy Media	1988-03-30	84
K880129	BRILLIANT GREEN BILE BROTH	Hardy Media	1988-03-30	84
K880106	ACETAMIDE AGAR SLANT	Hardy Media	1988-03-30	84
K880111	CYSTINE TRYPTIC MEDIUM W/SUCROSE	Hardy Media	1988-03-30	84
K880139	ONPG TEST REAGENT	Hardy Media	1988-03-30	84
K880115	NUTRIENT GELATIN	Hardy Media	1988-03-08	62
K874175	BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC	Otisville Biopharm, Inc.	1987-12-04	52
K874174	BIOTIS (TM) STARCH HYDROLYSIS WITH BCP	Otisville Biopharm, Inc.	1987-12-04	52
K873828	CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990	Lakewood Biochemical Co., Inc.	1987-10-06	15
K872691	IAFP UREA AGAR SLANT	I.A.F. Production, Inc.	1987-08-11	35
K870641	TRYPTONE BROTH, 2%	Hardy Media	1987-04-14	60
K864256	TRYPTONE WATER (1%)	Mds Laboratories, Inc.	1987-03-31	154
K864241	DNASE AGAR	Mds Laboratories, Inc.	1987-03-31	154
K862396	BIOTIS DECARBOXYLASE MEDIA, ARGININE	Otisville Biotech, Inc.	1986-07-03	9
K862398	BIOTIS DECARBOXYLASE MEDIA, ORNITHINE	Otisville Biotech, Inc.	1986-07-03	9
K862397	BIOTIS DECARBOXYLASE MEDIA, LYSINE	Otisville Biotech, Inc.	1986-07-03	9
K862392	BIOTIS MOTILITY TEST MEDIUM	Otisville Biotech, Inc.	1986-07-03	9
K850194	CAFFEIC ACID DISK	Remel Co.	1985-04-22	94
K850545	ACETATE DIFFERENTIAL AGAR	Hardy Media	1985-03-11	28
K850550	SIMMONS CITRATE AGAR	Hardy Media	1985-03-11	28
K844542	CYSTINE TRYPTIC AGAR W/DEXTROSE	bioMerieux, Inc.	1985-01-16	56
K844543	CYSTINE TRYPTIC AGAR W/LACTOSE	bioMerieux, Inc.	1985-01-16	56
K844544	CYSTINE TRYPTIC AGAR W/MALTOSE	bioMerieux, Inc.	1985-01-16	56
K844546	CYSTINE TRYPTIC AGAR W/SUCROSE	bioMerieux, Inc.	1985-01-16	56
K844545	CYSTINE TRYPTIC AGAR W/MANNITOL	bioMerieux, Inc.	1985-01-16	56
K844539	PHENOL RED BROTH W/CARBOHYDRATES	bioMerieux, Inc.	1985-01-07	47
K844540	CYSTINE TRYPTIC AGAR W/FRUCTOSE	bioMerieux, Inc.	1985-01-07	47
K843364	DIFFERENTIATION DISKS BILE ESCULIN	Difco Laboratories, Inc.	1984-09-07	10
K842871	HIPPURATE TEST REAGENT	Irvine Diagnostic Services	1984-08-07	15
K842869	DECARBOXYLASE TEST REAGENT	Irvine Diagnostic Services	1984-08-07	15
K842870	VOGES-PROSKAUER REAGENT A	Irvine Diagnostic Services	1984-08-03	11
K842868	HIPPURATE TEST DISKS	Irvine Diagnostic Services	1984-08-03	11
K842872	INDOLE REAGENT	Irvine Diagnostic Services	1984-08-03	11
K842867	VOGES-PROSKAUER REAGENT B	Irvine Diagnostic Services	1984-08-03	11
K842853	LYSINE IRON AGAR	Anarobe Systems	1984-08-03	14
K842855	CHRISTENSEN'S UREA AGAR	Anarobe Systems	1984-08-03	14
K842600	STREP-A-CHEK	E-Y Laboratories, Inc.	1984-07-11	8
K842299	ZINC DUST SUSPENSION	Irvine Diagnostic Services	1984-06-26	15
K842298	OXIDASE TEST STRIPS-OXIDASESURE	Irvine Diagnostic Services	1984-06-25	14
K842290	SPOT TEST NINHYDRIN REAGENTS	Difco Laboratories, Inc.	1984-06-22	11
K842291	SPOT TEST CATALASE TEST	Difco Laboratories, Inc.	1984-06-22	11
K842300	ONPG DISKS	Irvine Diagnostic Services	1984-06-22	11

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