Cleared Traditional

K850170 - HEART AID MODEL 97

K850170 is the FDA 510(k) clearance for HEART AID MODEL 97 by Cardiac Resucitator Corp.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850170 · Cardiac Resucitator Corp. · Cardiovascular device
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Feb 1985
Decision
29d
Days
Class 2
Risk

K850170 is an FDA 510(k) clearance for the HEART AID MODEL 97. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Cardiac Resucitator Corp. (Wilsonville, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 29 days - a notably fast clearance cycle.

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: 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 Cardiac Resucitator Corp. devices

Submission Details

510(k) Number K850170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1985
Decision Date February 14, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K850170.
LIFEPAK 8 MODIFICATION
K853732 · Physio-Control Corp. · Dec 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247 · Physio-Control Corp. · Apr 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248 · Physio-Control Corp. · Apr 1985
LIFEPAK 7D
K840047 · Physio-Control Corp. · Feb 1984
LIFEPAK 7P
K832876 · Physio-Control Corp. · Jan 1984