Cleared Traditional

K851139 - THUMPER CARDIOPULMONARY RESUSCITATOR 1005

K851139 is an FDA 510(k) clearance for THUMPER CARDIOPULMONARY RESUSCITATOR 1005, 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 55-day FDA review.

K851139 · Michigan Instruments, Inc. · Cardiovascular device
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May 1985
Decision
55d
Days
Class 2
Risk

K851139 is an FDA 510(k) clearance for the THUMPER CARDIOPULMONARY RESUSCITATOR 1005. 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 May 15, 1985 after a review of 55 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 - K851139

510(k) Number K851139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date May 15, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
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 K851139.
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MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
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KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822 · Keymed, Inc. · Jul 1984
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792451 · Pneupac , Ltd. · Feb 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792452 · Pneupac , Ltd. · Feb 1980