Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Onset Medical Corporation · Predicate Candidate Screening

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

126 daysmedian FDA review time

358 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K152498	SoloPath Re-Collapsible Access System	Onset Medical Corporation	2016-01-05	126	2
K121404	SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	Onset Medical Corporation	2013-05-03	358	0
K112629	ONSET ACCESS CATHETER SYSTEM	Onset Medical Corporation	2011-10-11	32	0
K100819	THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	Onset Medical Corporation	2010-08-02	132	1
K092014	SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	Onset Medical Corporation	2009-10-08	94	0
K062852	BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840	Onset Medical Corporation	2007-02-23	151	0
K061009	PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEU	Onset Medical Corporation	2006-05-02	20	9
K043254	PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL	Onset Medical Corporation	2005-02-10	78	0

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