Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KAI — Predicate Candidate Screening

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

28 daysmedian FDA review time
93 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833601ANTRUM & ATTIC MIRRORMicrotek Medical, Inc.1984-01-03830
K823915MIRROR TIPTreace Medical, Inc.1983-01-21240
K822374BUCKINGHAM ATTIC & ANTRUM MIRRORTreace Medical, Inc.1982-09-09340
K822261LARYNGEAL MIRRORSKelleher Corp.1982-08-30320
K822191HEAD MIRROR WITH HEADBANDKelleher Corp.1982-08-20280
K820354ATMOS MIRROR WARMERJedmed Instrument Co.1982-03-01210
K781750MIRROR WARMERArleton Technical Products, Inc.1979-01-17930
K770054MIRROR, NASO-PHARYNXWelch Allyn, Inc.1977-01-1880
K770053MIRROR, LARYNGEALWelch Allyn, Inc.1977-01-1880

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