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STAT Padz Sterile Adult Multi-Function Electrodes

by Zoll Medical Corp

510(k) K943698

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

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)SESE Substantially Equivalent · Traditional NumberK943698 Date28 Dec 1994ClearedStatusActive

Official records

Recalls

7 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0053-2015 FDA Class II initiated 16 Sep 2014
    • Terminated Z-0054-2015 FDA Class II initiated 16 Sep 2014
    • Terminated Z-0052-2015 FDA Class II initiated 16 Sep 2014
    • Terminated Z-0055-2015 FDA Class II initiated 16 Sep 2014

    Product sterility is not assured

  • 3 recalls, same reason

    • Terminated Z-2660-2014 FDA Class II initiated 26 Aug 2014
    • Terminated Z-2658-2014 FDA Class II initiated 26 Aug 2014
    • Terminated Z-2659-2014 FDA Class II initiated 26 Aug 2014

    Sterility of device is not assured

Timeline

8 dated events

  1. Cleared FDA 510(k) K943698
  2. Recall initiated FDA recalls Z-2660-2014
  3. Recall initiated FDA recalls Z-2658-2014
  4. Recall initiated FDA recalls Z-2659-2014
  5. Recall initiated FDA recalls Z-0053-2015
  6. Recall initiated FDA recalls Z-0054-2015
  7. Recall initiated FDA recalls Z-0052-2015
  8. Recall initiated FDA recalls Z-0055-2015

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  • Withdrawn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
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 STAT Padz Sterile Adult Multi-Function Electrodes are a type of adhesive electrode designed for use with automated external defibrillators (non-wearable) and cardiac monitoring devices. These electrodes facilitate defibrillation, cardioversion, and electrocardiogram (ECG) monitoring by providing conductive contact between the patient’s skin and the device.

Supplied sterile and intended for single-use, these electrodes are intended for adult patients and are compatible with Zoll Medical’s defibrillators and monitors. They are classified as Class III medical devices under FDA regulations (870.5310) and have received FDA 510(k) clearance (K943698) as substantially equivalent to a predicate device. Storage and handling follow standard sterile medical device protocols.

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