Atlas FDA

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

KTQ · Predicate Candidate Screening

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

22 daysmedian FDA review time
49 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3Atlantic Antibodies1989-02-17240
K812522RABBIT COMPLEMENTDutchland Laboratories, Inc.1981-09-23210
K812370GUINEA PIG COMPLEMENT REGULARDutchland Laboratories, Inc.1981-09-08190
K812369GUINEA PIG COMPLEMENT VIRUS ANTIBODYDutchland Laboratories, Inc.1981-09-08190
K791117RABBIT COMPLEMENTCalbiochem-Behring Corp.1979-08-03490
K790380LOW-TOX-H RABBIT COMPLEMENTCederlane Labs , Ltd.1979-03-21220

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