THUMPER— 510(k) K972525

Name: FDA 510(k) clearance K972525
Creator: U.S. Food and Drug Administration
Published: 1997-10-02

Substantially Equivalent

Michigan Instruments, Inc.

FDA 510(k) clearance K972525 for THUMPER, Substantially Equivalent on 1997-10-02. Applicant: Michigan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Michigan Instruments, Inc.
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 1997-07-07
Decision date: 1997-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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K211289 — RMU-2000 Automated Chest Compression System2021-11-09
K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

More clearances from Michigan Instruments, Inc.

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K073079 — THUMPER, MODEL: 10082008-02-14
K962237 — THUMPER CARDIOPULMONARY RESUSCITATOR1996-09-05
K895954 — LARYNGOSTAT LARYNGOSCOPE HANDLE1989-10-30
K851139 — THUMPER CARDIOPULMONARY RESUSCITATOR 10051985-05-15
K833879 — CARDIOPULMONARY RESUSCITATOR1983-12-27

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K972525

K-number listed on FDA's recall record

Z-1632-2018 — Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.Class III·Terminated·Michigan Instruments, Inc.·20180213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972525.

Data sourced from openFDA. This site is unofficial and independent of the FDA.