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HIGHPAK-12

by Ad Elektronik GmbH

510(k) K062331

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062331 Date10 Jul 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MPD
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The HIGHPAK-12 is an auxiliary power supply that provides AC or DC power to low‑energy DC defibrillators. It is designated for cardiovascular applications and delivers reliable power to support defibrillator operation.

The device is a Class 2 cardiovascular product (product code MPD) cleared through the traditional FDA 510(k) pathway (K062331) on 10 July 2007. It is manufactured by Ad Elektronik GmbH in Lutsen, Minnesota, United States, and is considered substantially equivalent to a predicate device.

Other devices from Ad Elektronik GmbH

Questions

AI-generated answers, 6 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 is the HIGHPAK-12 used for?

    The HIGHPAK-12 is used to provide reliable power to low-energy DC defibrillators for cardiovascular applications.

  • Is the HIGHPAK-12 a single-use device?

    The device data does not specify if the HIGHPAK-12 is single-use or reusable, but it is designed to support defibrillator operation.

  • What type of power does the HIGHPAK-12 supply?

    The HIGHPAK-12 supplies either AC or DC power to low-energy DC defibrillators.