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

E.F. Brewer Co. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883437DENTAL CHAIRE.F. Brewer Co.1988-10-12580
K850245BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEME.F. Brewer Co.1985-02-07160
K840866PORTASCOOT POWER SEATE.F. Brewer Co.1984-03-19210
K823270HEAVY-DUTY I.V. STANDE.F. Brewer Co.1982-11-17150

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