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

Hardy Media · Predicate Candidate Screening

114 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time

85 days90th percentile

114clearances measured

K-number	Device	Applicant	Decided	Review days
K880125	LOWENSTEIN-JENSEN, SELECTIVE	Hardy Media	1988-03-31	85
K880122	MIDDLEBROOK 7H9 BROTH	Hardy Media	1988-03-31	85
K880121	MOELLERS DECARBOXYLASE, BASE	Hardy Media	1988-03-31	85
K880134	MIDDLEBROOK 7H11 AGAR	Hardy Media	1988-03-31	85
K880126	LAURYL TRYPTOSE BROTH	Hardy Media	1988-03-31	85
K880124	LOWENSTEIN-JENSEN, W/NACL	Hardy Media	1988-03-31	85
K880131	LOWENSTEIN-JENSEN, GRUFT	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
K880123	LOWENSTEIN-JENSEN SLANT	Hardy Media	1988-03-31	85
K880116	MRVP BROTH	Hardy Media	1988-03-31	85
K880133	MIL MEDIUM	Hardy Media	1988-03-31	85
K880117	OF MEDIUM BASE	Hardy Media	1988-03-30	84
K880137	BHI WITH C & C SLANT	Hardy Media	1988-03-30	84
K880108	CORN MEAL W/POLYSORBATE 80	Hardy Media	1988-03-30	84
K880138	WALLENSTEIN MEDIUM SLANT	Hardy Media	1988-03-30	84
K880105	MULLER HINTON BROTH	Hardy Media	1988-03-30	84
K880140	BCYE AGAR	Hardy Media	1988-03-30	84
K880107	CAMPY BROTH	Hardy Media	1988-03-30	84
K880128	SABOURAUD DEXTROSE AGAR W/CHLORO	Hardy Media	1988-03-30	84
K880112	CYSTINE TRYPTIC MEDIUM W/ MALTOSE	Hardy Media	1988-03-30	84
K880113	CYSTINE TRYPTIC MEDIUM W/LACTOSE	Hardy Media	1988-03-30	84
K880141	BCYE, SELECTIVE (W/MPA)	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
K880132	DERMATOPHYTE TEST MEDIUM	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
K880142	TSA W/LEC. & TWEEN. 80	Hardy Media	1988-03-30	84
K880136	CETRIMIDE SELECTIVE AGAR	Hardy Media	1988-03-30	84
K880106	ACETAMIDE AGAR SLANT	Hardy Media	1988-03-30	84
K880130	ATS MEDIA	Hardy Media	1988-03-30	84
K880109	CYSTINE TRYPTIC MEDIUM BASE	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
K880114	NUTRIENT BROTH	Hardy Media	1988-03-08	62
K880115	NUTRIENT GELATIN	Hardy Media	1988-03-08	62
K880127	POTATO DEXTROSE AGAR	Hardy Media	1988-03-07	61
K870641	TRYPTONE BROTH, 2%	Hardy Media	1987-04-14	60
K870634	TETRATHIONATE BROTH	Hardy Media	1987-04-14	60
K870643	POTATO DEXTROSE AGAR	Hardy Media	1987-04-14	60
K870637	DERMATOPHYTE TEST MEDIUM	Hardy Media	1987-04-14	60
K870646	MIDDLEBROOK 7H10 AGAR	Hardy Media	1987-04-14	60
K870636	HEMOPHILUS ID QUAD PLATE	Hardy Media	1987-04-14	60
K870635	REGAN-LOWE MEDIUM	Hardy Media	1987-04-14	60
K870647	COLUMBIA CNA AGAR	Hardy Media	1987-04-14	60
K870650	NEOMYCIN ANAEROBIC BLOOD AGAR	Hardy Media	1987-04-14	60
K870640	CETRIMIDE SELECTIVE AGAR	Hardy Media	1987-04-14	60
K870642	COOKED MEAT MEDIUM WITH IRON	Hardy Media	1987-04-14	60
K870645	MIDDLEBROOK 7H11 SELECTIVE AGAR	Hardy Media	1987-04-14	60

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