FirstSave Biphasic Models 9200 and 9210

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

510(k) Number

K982264 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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

• Vivalink AED Defibrillator

  Class III

  FDA 510(k) K940445 Active Cleared 9 Feb 1995

• 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

• Are the FirstSave Biphasic Models 9200 and 9210 devices single-use or reusable, and what does that mean for maintenance and cleaning?

  The FirstSave Biphasic Models 9200 and 9210 are reusable non-sterile devices. Since they are not sterile out-of-the-box, they require proper cleaning, disinfection, and maintenance between uses to ensure reliability and safety. Follow manufacturer guidelines for cleaning protocols to prevent cross-contamination and maintain functionality for repeated use in pre-hospital, emergency, or clinical settings.

• What types of settings are these defibrillators intended for, and how does that impact their use?

  These devices are explicitly designed for pre-hospital, emergency, and clinical settings, meaning they are built to handle high-stakes cardiac arrest scenarios where immediate intervention is critical. Their biphasic waveform technology is optimized for resuscitation efforts in environments where rapid deployment and reliability are essential, such as ambulances, hospitals, or public access defibrillation programs.

• How do I know if a FirstSave Biphasic Model 9200 or 9210 device is compliant with U.S. regulatory requirements?

  Both models were granted Substantially Equivalent (SE) status via a traditional 510(k) clearance by the FDA, with review by the Cardiovascular Advisory Committee. They are classified as Class III devices under regulation 870.5310 and are tracked under the FDA’s K-number K982264. Compliance is ensured through this clearance process, which confirms they meet U.S. safety and performance standards for automated external defibrillators.

• What storage and handling guidelines should I follow for these devices?

  While specific storage instructions aren’t detailed in the data, reusable medical devices like these generally require standard medical device protocols to preserve functionality and sterility (where applicable). Store in a clean, dry environment away from extreme temperatures or direct sunlight, and follow manufacturer recommendations for maintenance schedules to ensure readiness for emergency use.