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OneStep Pediatric MFE's

by Zoll Medical Corporation

510(k) K110978

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)SESE Substantially Equivalent · Abbreviated NumberK110978 Date13 May 2011ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 OneStep Pediatric MFE's is an Automated External Defibrillator (Non-Wearable) Electrode, designed for pediatric use in cardiopulmonary resuscitation (CPR). It combines defibrillation, ECG monitoring, and pacing capabilities in a single, reusable electrode system tailored for children. The device is intended for use with Zoll defibrillators (R, M, and E Series) to deliver synchronized shocks, analyze heart rhythms, and provide pacing therapy when required.

Supplied as a single-use, disposable accessory, the OneStep Pediatric MFE's consists of conductive hydrogel, a metal conductor, and an adhesive perimeter for secure attachment. It is classified as a Class 3 Cardiovascular device under FDA regulation (870.5310) and cleared via an Abbreviated 510(k) pathway (K110978). The device is packaged in quantities of eight electrodes per case and is intended for use in emergency and pre-hospital settings where pediatric resuscitation may be required.

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