Cleared Traditional

K882513 - MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR

K882513 is an FDA 510(k) clearance for MODIFIED HEART*AID 97 AUTO. EXTERNAL DE..., manufactured by Cardiac Resucitator Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K882513 · Cardiac Resucitator Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
40d
Days
Class 2
Risk

K882513 is an FDA 510(k) clearance for the MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Cardiac Resucitator Corp. (Portland, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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

FDA 510(k) Submission Details - K882513

510(k) Number K882513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1988
Decision Date July 12, 1988
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 300
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K882513.
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988
EPICARDIA PC/FC
K883103 · Medicomp, Inc. · Sep 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · Mennen Medical, Inc. · Jul 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · Mortara Instrument, Inc. · Mar 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · Kontron Instruments, Inc. · Mar 1988
RHYTHMSCAN
K871572 · Brentwood Instruments, Inc. · Feb 1988