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Zoll M Series

by Zoll Medical Corp

510(k) K010257

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010257 Date28 Feb 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1472-04 FDA Unclassified (pre-2012) initiated 2 Aug 2004 on shared 510(k) K010257

    Visual Sreen display and audible prompt may not advise to 'Press Shock'

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 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 M Series is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. These devices are engineered to provide clear voice prompts, real-time rhythm analysis, and biphasic waveform defibrillation to improve resuscitation outcomes in both pre-hospital and public-access settings.

The Zoll M Series is intended for single-use in emergency scenarios and is supplied as a portable, non-reusable device. It is not MRI-compatible and requires proper storage in a dry, temperature-controlled environment to maintain functionality. The device holds FDA 510(k) clearance under classification III (device class=3) and is regulated under the U.S. regulation number 870.5310, with multiple registration numbers listed in the OpenFDA database.

Other devices from Zoll Medical Corporation

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Questions

AI-generated answers, 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.

  • What is the primary purpose of the Zoll M Series Automated External Defibrillator (AED) in emergency situations?

    The Zoll M Series is designed to deliver life-saving electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It uses clear voice prompts, real-time rhythm analysis, and biphasic waveform defibrillation to improve resuscitation outcomes in both pre-hospital and public-access settings, such as workplaces, schools, or public spaces.

  • Is the Zoll M Series intended for reuse, or is it meant to be used only once in an emergency?

    The Zoll M Series is explicitly intended for single-use in emergency scenarios. This design ensures reliability and safety during critical moments, as it is not engineered for reuse.

  • What storage conditions are required to maintain the functionality of the Zoll M Series?

    The device must be stored in a dry environment with temperature control to preserve its functionality. Avoiding moisture and extreme temperatures is essential, as these factors could compromise its performance in an emergency.

  • Does the Zoll M Series have any compatibility with MRI machines, and if not, why?

    No, the Zoll M Series is explicitly stated as *not* MRI-compatible. This is likely due to the potential interference from electromagnetic fields generated during MRI scans, which could disrupt the device’s electronics or compromise its safety during use.

  • How is the regulatory status of the Zoll M Series defined in the U.S., and what does this mean for buyers?

    The Zoll M Series holds FDA 510(k) clearance under classification III (device class=3), meaning it is regulated as a high-risk medical device. This clearance indicates that the device has been deemed *substantially equivalent* to a legally marketed predicate device, ensuring it meets stringent safety and effectiveness standards for use in sudden cardiac arrest scenarios.