# K011901: Firstsave Star Biphasic, Model 9210/9200

- Pathway: 510(k) (Traditional)
- Applicant: Survivalink Corp.
- Decided: Feb 1, 2002 after 228 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970741 (1997). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010214: Firstsave Biphasic Model #9200 and 9210, Survivalink Corp. (2001) Summary page 1.
- K993533: Powerheart Aecd, Cardiac Science, Inc. (2000) Summary page 1.

## Most influential descendants
- K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210 (2003), 10 descendants of its own
- K031987: Powerheart Aed G3, Model 9300 (2003), 8 descendants of its own
- K040438: Powerheart Aed G3A (2004), 6 descendants of its own
- K040637: Powerheart Aed G3 Pro (2004), 3 descendants of its own
- K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus (2011), 2 descendants of its own

## Recalls of this device
- May 24, 2004 · Not classified · Z-1033-04: Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be tu
- May 24, 2004 · Not classified · Z-1034-04: Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be tu

## Indications for use
The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm¹. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age².

Source page: https://510kreport.com/device/K011901
Methodology: https://510kreport.com/methodology