Cleared Traditional

K962237 - THUMPER CARDIOPULMONARY RESUSCITATOR

K962237 is an FDA 510(k) clearance for THUMPER CARDIOPULMONARY RESUSCITATOR, manufactured by Michigan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K962237 · Michigan Instruments, Inc. · Cardiovascular device
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Sep 1996
Decision
86d
Days
Class 2
Risk

K962237 is an FDA 510(k) clearance for the THUMPER CARDIOPULMONARY RESUSCITATOR. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Michigan Instruments, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Michigan Instruments, Inc. devices

FDA 510(k) Submission Details - K962237

510(k) Number K962237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1996
Decision Date September 05, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRM Compressor, Cardiac, External

All 12
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K962237.
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