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CPR Dura-Padz Reusable Defibrillation Electrode with Dura-Padz Gel

by Bio-Detek, Inc.

510(k) K150198

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 NumberK150198 Date2 May 2015ClearedStatusActive

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  • Withdrawn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
MKJ
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-Padz Gel is a reusable defibrillation electrode designed for use with automated external defibrillators (non-wearable). It delivers electrical shocks to the chest during cardiopulmonary resuscitation (CPR) to restore normal heart rhythm in cases of sudden cardiac arrest. The electrode incorporates a conductive gel to ensure consistent contact and effective energy transfer.

This device is intended for reusable clinical use and requires proper cleaning and maintenance between applications. Supplied sterile, it is classified as a Class III medical device under FDA regulations (870.5310) and holds a 510(k) clearance (K150198) for substantial equivalence. Storage and handling must comply with manufacturer guidelines to preserve sterility and functionality, ensuring safe and reliable performance in emergency resuscitation scenarios.

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