Cleared Special

K014157 - HEARTSTREAMFR2 AED WITH M3848A AND M3849A

K014157 is the FDA 510(k) clearance for HEARTSTREAMFR2 AED WITH M3848A AND M3849A by Philips Medical Systems. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K014157 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
29d
Days
Class 3
Risk

K014157 is an FDA 510(k) clearance for the HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Philips Medical Systems (Seattle, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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.

View all Philips Medical Systems devices

Submission Details

510(k) Number K014157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 19, 2001
Decision Date January 17, 2002
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 47
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K014157.
HEARTSTART MRX, MODEL M3535A
K031187 · Philips Medical Systems · Aug 2003
PHILIPS M5066A AND M5068A
K020715 · Philips Medical Systems · Nov 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · Philips Medical Systems · Jul 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · Philips Medical Systems · Jan 2002
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · Medical Devices, Inc. · Feb 2001
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
K992543 · Hewlett-Packard Co. · May 2000