Heartstream Electrode Adapter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984286 ↗

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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• Is the Heartstream Electrode Adapter designed for single-use or can it be reused in emergency cardiac care settings?

  The Heartstream Electrode Adapter is explicitly labeled as a reusable component for use in emergency cardiac care. Since it is not classified as sterile, it must be cleaned and maintained between uses according to the manufacturer’s guidelines to ensure proper functionality and hygiene.

• What types of defibrillators is this adapter compatible with, and how is it connected?

  The Heartstream Electrode Adapter is designed to interface external defibrillation pads with automated external defibrillators (non-wearable). It acts as a connector between the pads and the defibrillator’s electrode interface, ensuring reliable electrical conduction during resuscitation procedures.

• How should the Heartstream Electrode Adapter be stored, and are there any special handling requirements?

  While the device is reusable and not sterile, it should be stored in a clean, dry environment to prevent contamination or damage. Since it is intended for emergency use, it should be kept readily accessible in cardiac care settings. The manufacturer’s maintenance guidelines should be followed to ensure proper functionality between uses.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The Heartstream Electrode Adapter received FDA 510(k) clearance (K984286) under a special classification and is categorized as a Class III medical device (regulation number 870.5310). The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device.