510(k) Report

FDA applicant

Onset Medical Corporation

Irvine, CA8 decisions2005–201612 recalls

FDA records 8 decisions for Onset Medical Corporation (Irvine, CA) from 2005 to 2016: 8 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and EZN (Dilator, Catheter, Ureteral). Its devices cite 6 predicates, 4 of them its own earlier devices. 12 recalls are linked to its devices, 3 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Onset Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12009: 12010: 12011: 12013: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2019

2007: 92019: 3, 3 Class I
2007high 9 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Onset Medical Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter5decisions
  • EZNDilator, Catheter, Ureteral2decisions
  • DQYCatheter, Percutaneous1decision

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 20104cite it
  • K092014Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 20092cite it
  • K121404Solopath RE-Collapsible Access SystemOnset Medical Corporation · 20131cites it

What has FDA decided for it lately?

  • K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 20162 Class I recalls
  • K121404Solopath RE-Collapsible Access SystemOnset Medical Corporation · 2013
  • K112629Onset Access Catheter SystemOnset Medical Corporation · 2011
  • K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 20101 Class I recall
  • K092014Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2009
  • K062852Balloon Expandable Transseptal Indroducer, Models Beti-1840 and Beti-1870Onset Medical Corporation · 2007
  • K061009Pathway Balloon Expandable Ureteral Access Sheath, Model BeusOnset Medical Corporation · 20069 recalls
  • K043254Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access SheathOnset Medical Corporation · 2005

All 8 as Onset Medical Corporation →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K100819SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435…Apr 26, 2019Class I
  • K152498SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035…Apr 26, 2019Class I
  • K152498Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20Apr 26, 2019Class I
  • K061009Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog…Nov 30, 2007
  • K061009Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog…Nov 30, 2007
  • K061009Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog…Nov 30, 2007