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Zoll Pad with CPR Aid

by Zoll Medical Corp

510(k) K011541

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK011541 Date11 Apr 2002DecidedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MKJ
Device class
Class III
Regulation
21 CFR Part 870.5310
Advisory committee
Cardiovascular
FDA decision
ST

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Zoll Pad with CPR Aid is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to the chest during cardiac arrest. It combines defibrillation capabilities with a built-in CPR feedback mechanism to assist rescuers in performing effective chest compressions, improving resuscitation outcomes by synchronizing defibrillation with optimal CPR technique.

This device is intended for single-use in prehospital and emergency settings, including ambulances, public access defibrillation programs, and clinical environments. Supplied sterile and packaged for immediate use, it adheres to FDA 510(k) clearance (K011541) under Traditional review with Class III regulatory classification. The pad is compatible with Zoll defibrillators and must be used in accordance with manufacturer instructions to ensure proper function and safety.

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