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

JSG — Predicate Candidate Screening

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

25 daysmedian FDA review time

47 days90th percentile

209clearances measured

K-number	Device	Applicant	Decided	Review days
K882495	THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007	Lakewood Biochemical Co., Inc.	1988-07-01	15
K881550	OF BASAL MEDIUM	Acumedia Manufacturers, Inc.	1988-04-18	10
K881558	TRYPTOSE AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881523	DEXTROSE TRYPTONE BROTH	Acumedia Manufacturers, Inc.	1988-04-18	10
K881532	BLOOD AGAR BASE W/LOW PH	Acumedia Manufacturers, Inc.	1988-04-18	10
K881557	TRYPTONE	Acumedia Manufacturers, Inc.	1988-04-18	10
K881542	HEART INFUSION AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881563	TRYPTOSE PHOSPHATE BROTH	Acumedia Manufacturers, Inc.	1988-04-18	7
K881522	DEXTROSE AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881545	MALT EXTRACT	Acumedia Manufacturers, Inc.	1988-04-18	10
K881564	TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT	Acumedia Manufacturers, Inc.	1988-04-18	7
K881554	SKIM MILK DEHYDRATED	Acumedia Manufacturers, Inc.	1988-04-18	10
K881525	COOKED MEAT MEDIUM	Acumedia Manufacturers, Inc.	1988-04-18	10
K881562	TRYPTOSE BLOOD AGAR BASE	Acumedia Manufacturers, Inc.	1988-04-18	7
K881546	MALT EXTRACT AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881533	BLOOD AGAR BASE NO. 2	Acumedia Manufacturers, Inc.	1988-04-18	10
K881543	LETHEEN AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881548	MPH AGAR	Acumedia Manufacturers, Inc.	1988-04-18	10
K881528	CASEIN PEPTONE, LOW VITAMIN	Acumedia Manufacturers, Inc.	1988-04-18	10
K881541	GELATIN	Acumedia Manufacturers, Inc.	1988-04-18	10
K881531	BLOOD AGAR BASE, IMPROVED	Acumedia Manufacturers, Inc.	1988-04-18	10
K880947	NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE	Lakewood Biochemical Co., Inc.	1988-04-01	25
K880142	TSA W/LEC. & TWEEN. 80	Hardy Media	1988-03-30	84
K881115	BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-03-24	9
K880114	NUTRIENT BROTH	Hardy Media	1988-03-08	62
K875259	BITEK(TM) BLOOD CULTURE SYSTEM	Definitive Diagnostics, Inc.	1988-01-27	36
K875273	BITEK(TM) BLOOD CULTURE SYSTEM	Definitive Diagnostics, Inc.	1988-01-22	29
K875136	COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750	Lakewood Biochemical Co., Inc.	1988-01-12	28
K874538	TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516	Lakewood Biochemical Co., Inc.	1987-11-20	17
K873257	GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.	Central Media	1987-11-06	87
K873482	TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873480	TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873483	TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873325	SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873328	SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873221	BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873217	BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873219	BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873222	BRAIN HEART INFUSION BROTH W/X AND V - #T4540	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873220	BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873243	BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286	Lakewood Biochemical Co., Inc.	1987-09-22	39
K873236	BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904	Lakewood Biochemical Co., Inc.	1987-09-22	39
K873235	BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004	Lakewood Biochemical Co., Inc.	1987-09-22	39
K873232	BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P3302	Lakewood Biochemical Co., Inc.	1987-09-18	35
K873053	TRYPTIC SOY AGAR (TSA - PRODUCT #P2802)	Lakewood Biochemical Co., Inc.	1987-08-24	20
K873057	TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML	Lakewood Biochemical Co., Inc.	1987-08-24	20
K873059	TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML	Lakewood Biochemical Co., Inc.	1987-08-24	20
K873062	TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T9172	Lakewood Biochemical Co., Inc.	1987-08-24	20
K872681	IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD	I.A.F. Production, Inc.	1987-08-11	35
K872668	IAFP T.S.A. W/10% SHEEP BLOOD	I.A.F. Production, Inc.	1987-08-07	31

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