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Primedic Defibrillators-N/B

by Metronic Electronic GmbH

510(k) K921765

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 NumberK921765 Date3 Mar 1993ClearedStatusActive

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  • Withdrawn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, 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 Primedic Defibrillators-N/B is a low-energy DC defibrillator, including paddles, classified as a Class II medical device under FDA regulation 870.5300. It is designed for use in cardiovascular applications and has been determined to be substantially equivalent to a legally marketed predicate device.

This device received FDA 510(k) clearance under K921765 on March 3, 1993, following submission on April 14, 1992. It is manufactured by Metronic Electronic GmbH and is intended for use in clinical settings where cardiac defibrillation is required, based on its classification and authorization.

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 Primedic Defibrillators-N/B used for?

    The Primedic Defibrillators-N/B is designed for cardiovascular applications and is intended for use in clinical settings where cardiac defibrillation is required, based on its classification as a low-energy DC defibrillator with paddles under FDA regulation 870.5300.

  • How is the Primedic Defibrillators-N/B supplied and is it reusable?

    The device includes paddles as part of its system and is classified as a Class II medical device; however, the provided data does not specify whether it is single-use or reusable, so reuse protocols should be determined from the manufacturer's labeling and clinical guidelines.

  • What regulatory pathway was used for the Primedic Defibrillators-N/B?

    The Primedic Defibrillators-N/B received FDA 510(k) clearance under K921765 on March 3, 1993, following submission on April 14, 1992, and was determined to be substantially equivalent to a legally marketed predicate device.