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Portable Defibrillator/Monitor ED 425

by Honeywell, Inc.

510(k) K851092

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

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 · Traditional NumberK851092 Date10 Apr 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LDD
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a portable defibrillator/monitor, classified as a low-energy defibrillator (including paddles) under FDA device class 2. It is designed for cardiovascular applications and delivers defibrillation therapy while providing patient monitoring capabilities.

The device was granted FDA 510(k) clearance under number K851092 on April 10, 1985, following a traditional review process. It is supplied as a reusable, non-sterile device intended for use in clinical settings, with no indication of single-use use, MRI safety status, or specific storage requirements provided in the data.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What clinical functions does the ED 425 provide?

    The ED 425 combines low‑energy defibrillation, including paddle delivery, with real‑time patient monitoring. This dual capability lets clinicians treat arrhythmias while continuously observing vital signs, making it suitable for a range of cardiovascular emergencies in hospital or field settings.

  • Is the device supplied as a single‑use or reusable product?

    The device is supplied as a reusable, non‑sterile unit. It is intended for repeated use in clinical environments, with cleaning and maintenance performed according to the manufacturer’s instructions rather than being discarded after one procedure.

  • What regulatory pathway was used for market clearance?

    The ED 425 received FDA 510(k) clearance (K851092) on April 10, 1985 through a traditional review process, indicating it was found substantially equivalent to a legally marketed predicate device in the low‑energy defibrillator category.

  • Are there any special storage or sterility requirements?

    The data does not specify any particular storage conditions or sterility status. As a non‑sterile, reusable device, it should be stored in a clean, dry environment and sterilized or disinfected according to standard hospital protocols before patient use.

  • What size or model variations are available for the ED 425?

    The information provided lists only the ED 425 model; no additional sizes or variants are mentioned. Buyers should contact Honeywell directly if they need details on optional accessories or model extensions.