Dura Padz Reusable Electrode, Dura Padz Gel Disposable Hydrogel Model 8900-0300, 8900-0325

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

510(k) Number

K100565 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Bio-Detek, Inc. →

• What is the primary purpose of the Dura Padz reusable electrode and Dura Padz Gel disposable hydrogel in emergency settings?

  The Dura Padz reusable electrode (Model 8900-0300) and Dura Padz Gel disposable hydrogel (Model 8900-0325) are designed as adhesive electrodes specifically for automated external defibrillators (non-wearable). Their purpose is to provide a reliable conductive interface for delivering defibrillation shocks during cardiac emergencies, ensuring effective electrical contact with the patient’s chest.

• Are the reusable electrodes meant for single-use or repeated applications, and what cleaning instructions apply?

  The reusable electrode (Model 8900-0300) is explicitly designed for multiple applications. Between uses, it must be cleaned and disinfected according to the manufacturer’s guidelines to maintain safety and performance. This contrasts with the disposable hydrogel (Model 8900-0325), which is intended for single-use only.

• How are the Dura Padz electrodes packaged, and what sterility status applies to each model?

  The reusable electrode (Model 8900-0300) is not described as sterile in its packaging, but the disposable hydrogel (Model 8900-0325) is packaged sterile for immediate clinical use. Both models are supplied in sterile packaging as part of their regulatory compliance, though only the disposable version guarantees sterility out-of-box.

• What regulatory pathway was followed for FDA clearance of these electrodes, and what classification do they hold?

  The Dura Padz electrodes (both reusable and disposable) were cleared via the FDA’s 510(k) pathway under the traditional review process, with a decision date of November 16, 2010. They are classified as Class III devices under FDA regulation 870.5310, indicating they are intended for life-saving defibrillation applications and require stringent regulatory oversight.

• Are there specific sizes or models available for pediatric or adult use, and how do they differ?

  The provided data lists two models: 8900-0300 (reusable electrode) and 8900-0325 (disposable hydrogel), but it does not specify pediatric vs. adult sizing. The distinction lies in their reuse status—one is reusable with cleaning requirements, while the other is single-use and sterile. For precise sizing (e.g., pediatric vs. adult), refer to the manufacturer’s product documentation or catalog, as this data does not detail variations beyond the two models listed.