Vivalink AED Defibrillator

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

510(k) Number

K940445 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Firstsave Biphasic Model #9200 and 9210

  Class III

  FDA 510(k) K010214 Active Cleared 22 Feb 2001

• V2

  Class II

  FDA 510(k) K970481 Active Cleared 1 Jul 1997

• FirstSave Biphasic Models 9200 and 9210

  Class III

  FDA 510(k) K982264 Active Cleared 25 Jan 1999

• Firstsave Star Biphasic, Model 9210/9200

  Class III

  FDA 510(k) K011901 Active Cleared 1 Feb 2002

• Survivalink Multifunctional Electrode (SVL-9630)

  Class III

  FDA 510(k) K993072 Active Cleared 10 Dec 1999

• SVL-9130 Defibrillation Electrode

  Class III

  FDA 510(k) K971149 Active Cleared 23 Jun 1997

• Is the Vivalink AED Defibrillator intended for use by trained medical professionals only, or can untrained responders operate it safely with guidance?

  The Vivalink AED Defibrillator is designed for use by untrained responders in emergency situations. It provides voice prompts and visual guidance to assist users through CPR and defibrillation, ensuring rapid intervention without requiring prior medical training.

• What types of environments is the Vivalink AED Defibrillator approved for, and how is it typically deployed?

  The device is approved for pre-hospital and emergency settings, including public locations, workplaces, and ambulances. It is supplied as a reusable medical device, meaning it is intended for repeated use in multiple emergency scenarios after proper maintenance and cleaning.

• How does one determine if a specific Vivalink AED Defibrillator unit is compliant with U.S. regulatory standards?

  The Vivalink AED Defibrillator holds a FDA 510K clearance with the K-number K940445, confirming its compliance with U.S. regulatory standards. The device is classified as a Class III under FDA regulations (870.5310), and its clearance was granted through a traditional 510(k) review by the Cardiovascular (CV) Advisory Committee.

• Does the Vivalink AED Defibrillator require any special handling or storage conditions?

  The device is reusable and intended for long-term use in emergency settings, so it should be stored in a clean, dry environment as per manufacturer guidelines. Since it is not single-use, proper maintenance and periodic inspections are necessary to ensure functionality, though specific storage requirements are not detailed in the provided data.