Cleared Traditional

K801946 - CPR HELPER

K801946 is an FDA 510(k) clearance for CPR HELPER, manufactured by Cardia Concepts Corp.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K801946 · Cardia Concepts Corp. · Cardiovascular device
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Nov 1980
Decision
97d
Days
Class 2
Risk

K801946 is an FDA 510(k) clearance for the CPR HELPER. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Cardia Concepts Corp. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardia Concepts Corp. devices

FDA 510(k) Submission Details - K801946

510(k) Number K801946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1980
Decision Date November 19, 1980
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 26
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K801946.
HUNTLEIGH FLOWPAC FP2000
K871272 · Huntleigh Technology, Inc. · Jun 1987
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734 · Medasonics, Inc. · Feb 1986
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
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792454 · Pneupac , Ltd. · Feb 1980