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SVL-9130 Defibrillation Electrode

by Survivalink Corp.

510(k) K971149

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK971149 Date23 Jun 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1616-2008 FDA Unclassified (pre-2012) initiated 23 Jan 2008

    Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.

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  • Withdrawn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 SVL-9130 Defibrillation Electrode is a single-use device designed for use with semi-automatic external defibrillators (AEDs). It is classified as an Automated External Defibrillator (Non-Wearable) and functions to monitor heart rhythms and deliver electrical shocks to restore normal cardiac rhythm during cardiac arrest.

These electrodes are intended for single-use applications in emergency settings, such as public access defibrillation programs or pre-hospital care. They are non-sterile and supplied as part of a kit for immediate use. The device is regulated under FDA 510(k) clearance (K971149) and falls under product code MKJ, adhering to regulation 870.5310. Storage should follow manufacturer guidelines to maintain functionality until use.

Other devices from Survivalink Corp.

Questions

AI-generated answers, 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.

  • Are these electrodes reusable or intended for single-use only, and why does that matter in an emergency setting?

    The SVL-9130 Defibrillation Electrode is explicitly designed for single-use only. This is critical in emergency settings because single-use electrodes ensure sterility is not compromised, reducing the risk of infection when applied to patients in urgent cardiac arrest scenarios. Reuse could also lead to degradation of performance, as repeated use may affect conductivity or adhesive properties, potentially compromising the device’s ability to deliver effective defibrillation shocks.

  • How should these electrodes be stored, and what happens if they’re not stored properly?

    The SVL-9130 Defibrillation Electrode must be stored according to the manufacturer’s guidelines to maintain functionality until use. Improper storage—such as exposure to extreme temperatures, moisture, or direct sunlight—could degrade the adhesive, conductive gel, or overall integrity of the electrodes. This may impair their ability to adhere to the patient’s chest or deliver a proper defibrillation shock, potentially compromising treatment effectiveness in an emergency.

  • What types of defibrillators are these electrodes compatible with, and why is this important?

    The SVL-9130 Defibrillation Electrode is specifically designed for use with semi-automatic external defibrillators (AEDs). This compatibility ensures proper monitoring of heart rhythms and accurate delivery of defibrillation shocks, which is essential for restoring normal cardiac rhythm during cardiac arrest. Using them with incompatible devices could lead to incorrect readings or failed shock delivery, risking delayed or ineffective treatment.

  • Are these electrodes sterile, and if not, what precautions should be taken when using them?

    The SVL-9130 Defibrillation Electrode is non-sterile, meaning it is not intended for direct application to open wounds or sterile surgical environments. However, in emergency cardiac arrest scenarios, the risk of infection from non-sterile electrodes is generally outweighed by the urgency of treatment. Standard infection control practices, such as hand hygiene and proper electrode placement on intact skin, should still be followed to minimize risks.