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AccessAED Semi-Automatic External Defibrillators

by Access Cardiosystems, Inc.

510(k) K020984

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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)ST Traditional NumberK020984 Date14 Aug 2002DecidedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0199-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Device may fail to deliver shock due to a faulty circuit board

    • Terminated Z-0356-04 FDA Unclassified (pre-2012) initiated 19 Dec 2003

    Difibrillator may fail to operate due to a faulty component on the circuit board

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  • Withdrawn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 AccessAED Semi-Automatic External Defibrillators are classified as Automated External Defibrillators (Non-Wearable) under FDA nomenclature. These devices are designed to deliver an electric shock to restore normal heart rhythm in patients experiencing sudden cardiac arrest by analyzing heart rhythms and advising operators when defibrillation is required.

These semi-automatic defibrillators are intended for use in pre-hospital, emergency response, and public access settings. Supplied as reusable medical devices, they require proper training for operation and are subject to FDA 510(k) clearance under regulation number 870.5310. The devices are not single-use and must be maintained according to manufacturer guidelines, including periodic inspections and battery replacements as specified.

Other devices from Access Cardiosystems, Inc.

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.

  • Are these defibrillators intended for use by untrained individuals, or do they require operator training to operate safely and effectively?

    These devices are designed for use in pre-hospital, emergency response, and public access settings, but they require proper training for operation. The semi-automatic nature means the device analyzes heart rhythms and advises when defibrillation is needed, but the operator must still apply the paddles or pads and press the shock button. Training ensures safe and effective use, particularly in critical situations.

  • How are these defibrillators supplied, and what is the expected lifespan or maintenance schedule for the device?

    The AccessAED Semi-Automatic External Defibrillators are supplied as reusable medical devices, not single-use. They require periodic inspections and maintenance, including battery replacements as specified by the manufacturer. The manufacturer’s guidelines outline the maintenance schedule to ensure reliable performance over time.

  • What regulatory pathway was followed for FDA clearance of these defibrillators, and what does that mean for their use in clinical settings?

    These devices were cleared through the FDA’s 510(k) pathway under regulation number 870.5310, classified as substantially equivalent with subject-to-tracking requirements. This means the device was compared to a legally marketed predicate and determined to have similar intended use and technological characteristics, ensuring compliance with safety and performance standards for use in pre-hospital, emergency response, and public access settings.

  • Are there multiple models or sizes available for these defibrillators, or is this a single unified device?

    The provided data does not specify distinct models or sizes for the AccessAED Semi-Automatic External Defibrillators, but the device is listed under multiple registration numbers, which may correspond to variations or updates in the product line. For exact specifications on models or sizes, refer to the manufacturer’s documentation or catalog.