Cleared Traditional

K843547 - PACE *AID MODEL 52

K843547 is the FDA 510(k) clearance for PACE *AID MODEL 52 by Cardiac Resucitator Corp.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K843547 · Cardiac Resucitator Corp. · Cardiovascular device
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Dec 1984
Decision
98d
Days
Class 2
Risk

K843547 is an FDA 510(k) clearance for the PACE *AID MODEL 52. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Cardiac Resucitator Corp. (Walker, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 98 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

Submission Details

510(k) Number K843547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date December 17, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K843547.
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AMENDMENT LIFEPAK 100, NPN 045
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