510(k) Report

FDA applicant

Mc3 Incorporated

Dexter, MI6 decisions2017–20232 recalls

FDA records 6 decisions for Mc3 Incorporated (Dexter, MI) from 2017 to 2023: 6 510(k) clearances. Most are in product codes PZS (Dual Lumen Ecmo Cannula) and BYS (Oxygenator, Long Term Support Greater Than 6…). Its devices cite 5 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Mc3, Inc.”.

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 Mc3 Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12018: 22020: 12021: 12023: 1
2017high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

2in 2023

2023: 2
2017high 2 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Mc3 Incorporated by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PZSDual Lumen Ecmo Cannula3decisions
  • BYSOxygenator, Long Term Support Greater Than 6 Hours2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 20182cite it
  • K191935Nautilus Smart ECMO ModuleMc3 Incorporated · 20201cites it
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 20171cites it

What has FDA decided for it lately?

  • K232767Nautilus VF ECMO OxygenatorMc3, Inc. · 2023
  • K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021
  • K191935Nautilus Smart ECMO ModuleMc3 Incorporated · 20202 recalls
  • K182914MC3 Vascular Access Kit 21030Mc3 Incorporated · 2018
  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 2018
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017

All 4 as Mc3 Incorporated →All 2 as Mc3, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K191935NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support…Oct 11, 2023Class II
  • K191935NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support…Oct 11, 2023Class II