# K010214: Firstsave Biphasic Model #9200 and 9210

- Pathway: 510(k) (Special)
- Applicant: Survivalink Corp.
- Decided: Feb 22, 2001 after 30 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011901: Firstsave Star Biphasic, Model 9210/9200 (2002), 11 descendants of its own
- 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

## Recalls of this device
- Jan 23, 2008 · Not classified · Z-1714-2008: Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.

Source page: https://510kreport.com/device/K010214
Methodology: https://510kreport.com/methodology