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Survivalink Multifunctional Electrode (SVL-9630)

by Survivalink Corp.

510(k) K993072

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 NumberK993072 Date10 Dec 1999ClearedStatusActive

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  • Withdrawn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 Survivalink Multifunctional Electrode (SVL-9630) is a reusable electrode designed for use with automated external defibrillators (non-wearable). It is intended for delivering defibrillation shocks to restore normal heart rhythm during cardiac arrest by adhering to the chest wall and conducting electrical impulses.

This device is supplied as a reusable component, intended for use in emergency cardiac care settings. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510(k) clearance through a traditional review process. The electrode must be cleaned and maintained according to manufacturer instructions to ensure proper function and safety.

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