Cleared Special

K110168 - ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE

K110168 is an FDA 510(k) clearance for ZOLL E SERIES WITH 2010 AHA GUIDLINES S..., manufactured by Zoll Medical Corporation, World Wide Headquarters. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K110168 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
28d
Days
Class 3
Risk

K110168 is an FDA 510(k) clearance for the ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Zoll Medical Corporation, World Wide Headquarters (Chelsmford, US). The FDA issued a Cleared decision on February 17, 2011 after a review of 28 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.

FDA 510(k) Submission Details - K110168

510(k) Number K110168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2011
Decision Date February 17, 2011
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 222
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K110168.
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K103567 · Physio-Control, Inc. · Mar 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
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K102972 · Physio-Control, Inc. · Dec 2010
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K100565 · Bio-Detek, Inc. · Nov 2010