Atlas FDA

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

BWB · Predicate Candidate Screening

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

55 daysmedian FDA review time
57 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.1988-11-14120
K880318ROVENSTEIN FORCEPSEastmed Enterprises, Inc.1988-03-21550
K880319MAGILL FORCEPSEastmed Enterprises, Inc.1988-03-21550
K840313CAT. 9 ANESTHESIOLOGY RESPIRATORY DEVImm Enterprises , Ltd.1984-02-04110
K834169OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.1984-01-17570
K820451INTRODUCER FOR ENDOTRACHEAL TUBEImed Corp.1982-03-26360

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