# K982264: Firstsave Biphasic Models 9200 and 9210

- Pathway: 510(k) (Traditional)
- Applicant: Survivalink Corp.
- Decided: Jan 25, 1999 after 210 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955628 (1996). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970481: V2, Survivalink Corp. (1997) Summary page 1.
- K955628: Fore Runner External Defibrillator/Defibrillator Pads, Heartstream, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K122758: Powerheart G5 Aed (2014), 1 descendant of its own

## Indications for use
The FirstSave STAR Biphasic AED is intended for use by or on the order of a Physician or persons licensed by State law. It is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient’s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The FirstSave STAR Biphasic AED is intended to be used on patients older than eight years'.

Source page: https://510kreport.com/device/K982264
Methodology: https://510kreport.com/methodology