Atlas FDA

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

LKA · Predicate Candidate Screening

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

35 daysmedian FDA review time
38 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872687IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENTI.A.F. Production, Inc.1987-08-11350
K872688IAFP MUELLER HINTON AGAR W/5% SHEEP BLOODI.A.F. Production, Inc.1987-08-11350
K872686IAFP MUELLER HINTON AGARI.A.F. Production, Inc.1987-08-11350
K833218YEAST BEEF AGAR-ANTIBIOTIC MED.4Acumedia Manufacturers, Inc.1983-10-27380
K833207AK AGAR 2Acumedia Manufacturers, Inc.1983-10-27380

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