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

Arplay Medical S.A. — Predicate Candidate Screening

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

90 daysmedian FDA review time

540 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K010065	CRANIAL STEREOTACTIC EQUIPMENT	Arplay Medical S.A.	2002-07-02	540
K004023	INTRA OPERATIVE RADIATION THERAPY	Arplay Medical S.A.	2001-09-21	268
K003779	IMMOBILIZATION SYSTEM FOR ENT	Arplay Medical S.A.	2001-07-12	217
K003778	BREAST-BOARD (MULTIPLE)	Arplay Medical S.A.	2001-06-08	183
K010174	TRAY ADAPTERS, MULTIPLE	Arplay Medical S.A.	2001-04-18	90
K010172	LEAD BLOCKS	Arplay Medical S.A.	2001-04-18	90
K010063	COUCH FOR TOTAL BODY RADIATION	Arplay Medical S.A.	2001-04-02	84
K010062	STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM	Arplay Medical S.A.	2001-03-13	64
K004015	BEAM BLOCK TRAYS	Arplay Medical S.A.	2001-03-13	76

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