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Firstsave Biphasic Model #9200 and 9210

by Survivalink Corp.

510(k) K010214

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 · Special NumberK010214 Date22 Feb 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1714-2008 FDA Unclassified (pre-2012) initiated 23 Jan 2008

    Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.

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  • Withdrawn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 FirstSave Biphasic Models 9200 and 9210 are automated external defibrillators (non-wearable), designed to deliver biphasic waveforms for the treatment of sudden cardiac arrest. These devices provide automated voice prompts and shock delivery to restore normal heart rhythm in victims of ventricular fibrillation or pulseless ventricular tachycardia.

Supplied as non-sterile, reusable devices, these models are intended for use in pre-hospital and emergency medical settings. They comply with FDA 510(k) clearance under classification III (K010214) and are regulated under 21 CFR 870.5310. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and safety for repeated use in emergency scenarios.

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.

  • What types of cardiac emergencies are the FirstSave Biphasic Models 9200 and 9210 designed to treat, and how do they work?

    The FirstSave Biphasic Models 9200 and 9210 are automated external defibrillators (non-wearable) specifically designed to treat sudden cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. They deliver biphasic waveforms to restore a normal heart rhythm. The devices provide automated voice prompts to guide rescuers through the process, including when to deliver a shock, ensuring proper use in emergency situations.

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

    The FirstSave Biphasic Models 9200 and 9210 are non-sterile, reusable devices, meaning they are built for repeated use in pre-hospital and emergency medical settings. To maintain functionality and safety, they must follow the manufacturer’s guidelines for storage and periodic maintenance, as outlined by Survivalink Corp. This ensures reliability in critical situations where repeated use may be necessary.

  • Where are these devices primarily intended for use, and what regulatory pathway was followed for clearance?

    These devices are intended for pre-hospital and emergency medical settings, such as ambulances, fire stations, or public access defibrillation programs. They were cleared through the FDA 510(k) pathway under classification III (K010214) with a special clearance type, meaning their safety and effectiveness were compared to a legally marketed predicate device. The regulatory route confirms compliance with 21 CFR 870.5310 for automated external defibrillators.

  • How do I know if a FirstSave Biphasic Model 9200 or 9210 is suitable for my facility’s needs?

    Both models are designed for emergency cardiac arrest response, delivering biphasic shocks for ventricular fibrillation or pulseless ventricular tachycardia. Since they are reusable and intended for pre-hospital and emergency medical use, they are ideal for settings like EMS agencies, hospitals, or public venues where rapid defibrillation is critical. Verify compatibility with your facility’s protocols and ensure proper training for operators, as the device relies on automated voice prompts for guidance.