Atlas FDA

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

Hosmer Dorrance Corp. · Predicate Candidate Screening

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

14 daysmedian FDA review time
28 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K822632ELBOW PROSTHESISHosmer Dorrance Corp.1982-09-14140
K821704FRACTURE BRACINGHosmer Dorrance Corp.1982-06-24220
K801788HUMEROUS FRACTURE BRACE, ULNA FRACTUREHosmer Dorrance Corp.1980-08-0790
K780892FRACTURE BRACINGHosmer Dorrance Corp.1978-06-13130
K780890CAPP TERMINAL DEVICEHosmer Dorrance Corp.1978-06-13130
K780891POST-OPERATIVE HIP ORTHOSISHosmer Dorrance Corp.1978-06-13130
K7613134-BAR KNEE-SHIN SET-UPHosmer Dorrance Corp.1977-01-10280
K761314FLEXION-BRAKING KNEE-SHIN ASSEMBLYHosmer Dorrance Corp.1977-01-10180
K761312ORTHOTIC BRACINGHosmer Dorrance Corp.1977-01-10180

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