Cleared Special

K102972 - LIFEPAK 12

K102972 is an FDA 510(k) clearance for LIFEPAK 12, manufactured by Physio-Control, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 77-day FDA review.

K102972 · Physio-Control, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
77d
Days
Class 3
Risk

K102972 is an FDA 510(k) clearance for the LIFEPAK 12. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 77 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 Physio-Control, Inc. devices

FDA 510(k) Submission Details - K102972

510(k) Number K102972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date December 22, 2010
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 212
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K102972.
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110154 · Zoll Medical Corporation, World Wide Headquarters · Feb 2011
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110168 · Zoll Medical Corporation, World Wide Headquarters · Feb 2011
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
K103186 · Leonhard Lang GmbH · Feb 2011
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
K100565 · Bio-Detek, Inc. · Nov 2010
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
K091561 · ZOLL Medical Corporation · Sep 2010
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
K092391 · Concord Medical Products · Apr 2010