510(k) Report

FDA applicant

Reflow Medical, Inc.

San Clemente, CA20 decisions2010–20261 recall

FDA records 20 decisions for Reflow Medical, Inc. (San Clemente, CA) from 2010 to 2026: 19 510(k) clearances and 1 De Novo grant. Most are in product codes DQY (Catheter, Percutaneous) and SEU (Peripheral Temporary And Retrievable Stent…). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 16 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Reflow Medical”.

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 Reflow Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2010: 12012: 12013: 12014: 22015: 12016: 12017: 22018: 12019: 12020: 42021: 12024: 12025: 22026 (partial year): 1
2010high 4 (2020) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1, 1 Class I
2010high 1 (2017) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Reflow Medical, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Reflow Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQYCatheter, Percutaneous18decisions
  • SEUPeripheral Temporary And Retrievable Stent System1decision
  • PDUCatheter For Crossing Total Occlusions1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 111 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 8 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 16 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132420Wingman Extendable Tip Support CatheterReflow Medical · 20132cite it
  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 20142cite it
  • K173662speX Support CatheterReflow Medical, Inc. · 20172cite it
  • K201811coraForce and coraFlex Support CathetersReflow Medical, Inc. · 20201cites it
  • K190393Wingman 14C Crossing CatheterReflow Medical, Inc. · 20191cites it
  • K200094speX LP Support CatheterReflow Medical · 20201cites it

What has FDA decided for it lately?

  • K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
  • K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc. · 2025
  • DEN240048Spur Peripheral Retrievable Stent SystemReflow Medical, Inc. · 2025
  • K233350SINC Support CatheterReflow Medical, Inc. · 2024
  • K210188coraCrossReflow Medical · 2021
  • K201811coraForce and coraFlex Support CathetersReflow Medical, Inc. · 2020
  • K200094speX LP Support CatheterReflow Medical · 2020
  • K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020

All 10 as Reflow Medical, Inc. →All 10 as Reflow Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141547Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US…Mar 22, 2017Class I