# Onset Medical Corporation

- Location (FDA's records): Irvine, CA
- FDA decisions: 8 (2005–2016): 8 510(k) clearances
- Product codes: DYB (5), EZN (2), DQY (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 12 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Reverse Medical Corporation: 1 (https://510kreport.com/company/reverse-medical)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Transaortic Medical, Inc.: 1 (https://510kreport.com/company/transaortic-medical)

## Its most-cited devices
- K100819: The Solopath Balloon Expandable Transfemoral Introducer (2010), cited by 4
- K092014: Solopath Balloon Expandable Transfemoral Introducer (2009), cited by 2
- K121404: Solopath RE-Collapsible Access System (2013), cited by 1

## Recent decisions
- K152498: SoloPath Re-Collapsible Access System (Jan 5, 2016)
- K121404: Solopath RE-Collapsible Access System (May 3, 2013)
- K112629: Onset Access Catheter System (Oct 11, 2011)
- K100819: The Solopath Balloon Expandable Transfemoral Introducer (Aug 2, 2010)
- K092014: Solopath Balloon Expandable Transfemoral Introducer (Oct 8, 2009)
- K062852: Balloon Expandable Transseptal Indroducer, Models Beti-1840 and Beti-1870 (Feb 23, 2007)
- K061009: Pathway Balloon Expandable Ureteral Access Sheath, Model Beus (May 2, 2006)
- K043254: Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath (Feb 10, 2005)

Source page: https://510kreport.com/company/onset-medical