Atlas FDA

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

Interstate Media — Predicate Candidate Screening

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

20 daysmedian FDA review time
20 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K821418TRYPTOSE BLOOD AGAR W/5% SHEEP BLOODInterstate Media1982-06-01200
K821430MUELLER HINTON MEDIUMInterstate Media1982-06-01200
K821429MUELLER HINTON MED. W/5% SHEEP BLOODInterstate Media1982-06-01200
K821427MANNITOL SALT AGARInterstate Media1982-06-01200
K821419EMB AGARInterstate Media1982-06-01200
K821422SS AGARInterstate Media1982-06-01200
K821425COLUMBIA BLOOD AGAR W/5% SHEEP BLOODInterstate Media1982-06-01200
K821428MUELLER HINTON CHOCOLATE MED. ENRICHEDInterstate Media1982-06-01200
K821420EMB AGARInterstate Media1982-06-01200
K821426STAPHYLOCOCCUS MEDIUM 1100Interstate Media1982-06-01200
K821417TRYPTIC SOY AGAR W/10% SHEEP BLOODInterstate Media1982-06-01200
K821424TRYPTIC SOY AGAR W/5% SHEEP BLOODInterstate Media1982-06-01200
K821423MACCONKEY AGARInterstate Media1982-06-01200
K821421HEKTOEN ENTERIC AGARInterstate Media1982-06-01200
K821431XLD AGARInterstate Media1982-06-01200

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