Atlas FDA

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

Proto-Med, Inc. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K844852THE GENERIC OXYGEN CONCENTRATORProto-Med, Inc.1984-12-27140
K822301ROYAL 1 OXYGEN CONCENTRATORProto-Med, Inc.1982-08-19160
K820115EMMETT IUD THREAD RETREIVERProto-Med, Inc.1982-02-05180
K811761THE EMMETT IUD THREAD RETRIEVERProto-Med, Inc.1981-09-21910

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