Atlas FDA

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

Denver Splint Co. — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940798SHIPPERT PRESSURE BANDAGEDenver Splint Co.1994-09-282180
K940133THE EXPANDACELL EAR PACKDenver Splint Co.1994-05-231400
K935724THE EXPANDACELL SINUS PACKDenver Splint Co.1994-05-121620
K922062THE DENVER CAUTERYDenver Splint Co.1993-01-122530

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