Cleared Traditional

K012197 - POWERHEART CARDIAC RHYTHM MODULE

K012197 is an FDA 510(k) clearance for POWERHEART CARDIAC RHYTHM MODULE, manufactured by Cardiac Science, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K012197 · Cardiac Science, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
126d
Days
Class 3
Risk

K012197 is an FDA 510(k) clearance for the POWERHEART CARDIAC RHYTHM MODULE. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Cardiac Science, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012197

510(k) Number K012197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date November 16, 2001
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 223
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K012197.
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · Philips Medical Systems · Jan 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · Philips Medical Systems · Jan 2002
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
K011144 · Medtronic Physio-Control Corp. · Dec 2001
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K012428 · Medtronic Physio-Control Corp. · Sep 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · Medical Research Laboratories, Inc. · Sep 2001
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
K003548 · Padpro, LLC · Sep 2001
K012197 · POWERHEART CARDIAC RHYTHM MODULE
Download PDF FDA Summary Cardiac Science, Inc.