Cleared Traditional

K843547 - PACE *AID MODEL 52

K843547 is an FDA 510(k) clearance for PACE *AID MODEL 52, 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 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

FDA 510(k) Submission Details - K843547

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
Combination Product No
PCCP Authorized No
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.

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 K843547.
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596 · Cardiac Resucitator Corp. · Mar 1985
HEART AID MODEL 97
K850170 · Cardiac Resucitator Corp. · Feb 1985
PACE AID MODEL 53
K844811 · Cardiac Resucitator Corp. · Jan 1985
HEART-AID MODEL 80
K843358 · Cardiac Resucitator Corp. · Nov 1984
LIFEPAK 7D
K840047 · Physio-Control Corp. · Feb 1984
LIFEPAK 7P
K832876 · Physio-Control Corp. · Jan 1984