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

Hexcel Medical — Predicate Candidate Screening

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

19 daysmedian FDA review time

85 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K840416	HEXCELITE	Hexcel Medical	1984-03-23	52
K820890	URETHANE ORTHOPAEDIC CASTING TAPE	Hexcel Medical	1982-06-23	85
K812687	BRIGHAM II TOTAL HIP SYSTEM	Hexcel Medical	1981-10-02	10
K812669	SEATTLE II TOTAL HIP SYSTEM	Hexcel Medical	1981-10-02	11
K812068	PROPOSED CONTROLS FOR DOSIMETRIC RELEASE	Hexcel Medical	1981-09-08	49
K811164	URETHANE ORTHOPAEDIC CASTING TAPE	Hexcel Medical	1981-05-27	29
K810956	MARCOVE HUMERAL ROD	Hexcel Medical	1981-04-17	10
K810957	MARCOVE INTRAMEDULLARY ROD	Hexcel Medical	1981-04-17	10
K810230	CONDYLAR KNEE W/METAL ENCAPSULATED TIB	Hexcel Medical	1981-03-06	38
K800051	HEXCEL FEMORAL COMPONENT HIP PROSTHESIS	Hexcel Medical	1980-01-28	19
K800050	ANITOMIC TOTAL HIP SYSTEM	Hexcel Medical	1980-01-24	15
K781971	KNEE SYSTEM, QUADRAXIAL CONSTRAINED	Hexcel Medical	1979-04-04	128
K760841	HEXCELITE SHEET SPLINTS	Hexcel Medical	1976-11-01	19

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