510(k) Report

FDA applicant

Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

Dexter, MI2 decisions2023–20231 recall

FDA records 2 decisions for Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (Dexter, MI) in 2023: 2 510(k) clearances. All are in product code QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2023high 1 (2025) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 20231cites it

What has FDA decided for it lately?

  • K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 2023
  • K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · 20231 recall

All 2 as Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K250199MC3 VitalFlow Console, REF 58100; Blood pump of ecmoOct 3, 2025Class II

Other applicant names beginning “Michigan”

FDA records each applicant name separately; these may or may not be the same firm.

Michigan Instruments, Inc. 7