# K003565: Heartstream FR2 Aed, Model M3860A,M3861A

- Pathway: 510(k) (Special)
- Applicant: Agilent Technologies, Inc.
- Decided: Dec 20, 2000 after 30 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has 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
- K023854: Samaritan Aed, Model Sam-01 (2003), 3 descendants of its own
- K111693: Philips Heartstart FR3 Automated External Defibrillator (2011), 2 descendants of its own
- K040904: Philips Heartstart Home Defibrillator, Model M5068A (2004), 2 descendants of its own
- K041067: Heartsine Samaritan Pad (2004), 2 descendants of its own
- K123881: Heartsine Samaritan Pad 350P (2013), 1 descendant of its own

## Recalls of this device
- Sep 22, 2010 · Not classified · Z-0487-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0483-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0485-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0486-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0488-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0484-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- May 28, 2010 · Not classified · Z-0470-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0472-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0473-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0471-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- Feb 28, 2007 · Not classified · Z-0641-2007: Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing int
- Dec 19, 2006 · Not classified · Z-0308-2007: Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation

Source page: https://510kreport.com/device/K003565
Methodology: https://510kreport.com/methodology