Onset Medical Corporation

Mission Viejo, CA, US

Onset Medical Corporation appears in FDA device records in Mission Viejo, CA. FDA records list 8 510(k) clearances between 2005-02-10 and 2016-01-05, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 8
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 8 510(k) clearances for Onset Medical Corporation between 2005 and 2016. The busiest year on record is 2005, with 1. The most recent is 2016, with 1.

Clearances by year, as a table

510(k) clearance decisions for Onset Medical Corporation, by decision year
Year	Clearances
2005	1
2006	1
2007	1
2009	1
2010	1
2011	1
2013	1
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K152498	SoloPath Re-Collapsible Access System	DYB	Substantially Equivalent	2016-01-05
K121404	SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM	DYB	Substantially Equivalent	2013-05-03
K112629	ONSET ACCESS CATHETER SYSTEM	DQY	Substantially Equivalent	2011-10-11
K100819	THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	DYB	Substantially Equivalent	2010-08-02
K092014	SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER	DYB	Substantially Equivalent	2009-10-08
K062852	BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870	DYB	Substantially Equivalent	2007-02-23
K061009	PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS	EZN	Substantially Equivalent	2006-05-02
K043254	PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH	EZN	Substantially Equivalent	2005-02-10

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain