Atlas FDA

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

Biomedia, Inc. — Predicate Candidate Screening

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

23 daysmedian FDA review time
79 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K821300#2010 CAMPHYLOBACTER AGARBiomedia, Inc.1982-06-02290
K821302#50003 QUAD DIAGNOSTIC SYSTEMBiomedia, Inc.1982-06-01280
K821301#50002 QUAD DIAGNOSTIC SYSTEMBiomedia, Inc.1982-06-01280
K821108BI PLATE-XLD/HEKTOEN #30012Biomedia, Inc.1982-05-13230
K811474TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMBBiomedia, Inc.1981-06-18230
K811473MUELLER HINTON AGAR W/5% SHEEP BLOODBiomedia, Inc.1981-06-18230
K811477MACCONKEY AGARBiomedia, Inc.1981-06-18230
K811475TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOODBiomedia, Inc.1981-06-18230
K811478EMB AGAR, LEVINEBiomedia, Inc.1981-06-18230
K811471MUELLER HINTON AGARBiomedia, Inc.1981-06-18230
K811472MUELLER HINTON AGAR, POURED INTO A PLATEBiomedia, Inc.1981-06-18230
K811479CHODOLATE AGAR, ENRICHEDBiomedia, Inc.1981-06-18230
K811476THAYER MARTIN AGARBiomedia, Inc.1981-06-18230
K802127BACITRACIN DIFFERENTIATION DISCBiomedia, Inc.1980-09-16130
K791413CULTURE AND SENSITIVITY KITBiomedia, Inc.1979-10-17790
K791414DTM (DERMATOPHYTE TEST MEDIUM) AGARBiomedia, Inc.1979-10-17790
K790369EMB/MUELLER-HINTON AGARBiomedia, Inc.1979-04-23600
K790469STREP BLOOD AGAR-5% SHEEP BLOODBiomedia, Inc.1979-04-04300
K790368MODIFIED THAYER MARTIN AGARBiomedia, Inc.1979-03-21270

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