510(k) Report

FDA applicant

Michigan Instruments, Inc.

Grand Rapids, MI7 decisions1981–20083 recalls

FDA records 7 decisions for Michigan Instruments, Inc. (Grand Rapids, MI) from 1981 to 2008: 7 510(k) clearances. Most are in product codes DRM (Compressor, Cardiac, External) and CCW (Laryngoscope, Rigid). Its devices cite 3 predicates, 2 of them its own earlier devices. 3 recalls are 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 Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Michigan”

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