Cleared Special

K080232 - ZOLL E SERIES 12SL

K080232 is an FDA 510(k) clearance for ZOLL E SERIES 12SL, 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 84-day FDA review.

K080232 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
84d
Days
Class 3
Risk

K080232 is an FDA 510(k) clearance for the ZOLL E SERIES 12SL, ANALYSIS OPTION. 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 April 23, 2008 after a review of 84 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 Zoll Medical Corporation, World Wide Headquarters devices

FDA 510(k) Submission Details - K080232

510(k) Number K080232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2008
Decision Date April 23, 2008
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 114
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K080232.
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