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

Leventon, S.A. — Predicate Candidate Screening

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

46 daysmedian FDA review time

189 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K053149	SPIRO-BALL	Leventon, S.A.	2005-12-13	33	0
K040752	DOSI-FUSER	Leventon, S.A.	2004-04-07	14	0
K994074	TRI-BALL	Leventon, S.A.	2000-06-08	189	0
K952810	DOSI-FLOW, MODELS 20 & 30	Leventon, S.A.	1995-09-08	81	0
K851058	DOSI FLOW	Leventon, S.A.	1985-04-29	46	1

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