Cleared Traditional

K821152 - HEART AID #90

K821152 is an FDA 510(k) clearance for HEART AID #90, manufactured by Cardiac Resucitator Corp.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K821152 · Cardiac Resucitator Corp. · Cardiovascular device
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Aug 1982
Decision
102d
Days
Class 2
Risk

K821152 is an FDA 510(k) clearance for the HEART AID #90. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Cardiac Resucitator Corp. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Cardiac Resucitator Corp. devices

FDA 510(k) Submission Details - K821152

510(k) Number K821152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date August 06, 1982
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 56
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K821152.
LIFEPAK 7P
K832876 · Physio-Control Corp. · Jan 1984
PACE* AID MODEL 50
K820507 · Cardiac Resucitator Corp. · Aug 1982
HEART *AID, #80
K820609 · Cardiac Resucitator Corp. · Aug 1982
HEART*AID, ALS, MODEL 95
K821673 · Cardiac Resucitator Corp. · Aug 1982
PACE *AID
K813553 · Cardiac Resucitator Corp. · Jan 1982