510(k) Report

FDA applicant

Reverse Medical Corporation

Irvine, CA10 decisions2009–20150 recalls

FDA records 10 decisions for Reverse Medical Corporation (Irvine, CA) from 2009 to 2015: 10 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and KRD (Device, Vascular, For Promoting Embolization). Its devices cite 22 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

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 Reverse Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12011: 32012: 12013: 32014: 12015: 1
2009high 3 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Reverse Medical Corporation by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous5decisions
  • KRDDevice, Vascular, For Promoting Embolization4decisions
  • MMXDevice, Percutaneous Retrieval1decision

Whose devices does it build on?

Its devices cite 22 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 7 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.

  • K110055Reverse Medical Reflex Guide CatheterReverse Medical Corporation · 20115cite it
  • K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 20134cite it
  • K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 20153cite it
  • K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 20132cite it
  • K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 20142cite it
  • K122684Reverse Medical MicrocatheterReverse Medical Corporation · 20121cites it

What has FDA decided for it lately?

  • K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
  • K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
  • K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  • K130858Reverse Medical MicrocatheterReverse Medical Corporation · 2013
  • K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
  • K122684Reverse Medical MicrocatheterReverse Medical Corporation · 2012
  • K112262Reflex Ballon Guide CatheterReverse Medical Corporation · 2011
  • K102418Reverse Medical Report Guide Catheter SystemReverse Medical Corporation · 2011

All 10 as Reverse Medical Corporation →