# K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies, Inc.
- Decided: May 2, 2001 after 142 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
93 later devices descend from it; 5 cite it directly.
1 of 94 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
- K022732: Infant/Child Reduced Energy Electrodes (2002), 75 descendants of its own
- K033474: Zoll Aed Plus (2004), 72 descendants of its own
- K042007: Zoll E Series Defibrillator (2005), 64 descendants of its own
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series (2009), 27 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own

## Recalls of this device
- 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.

Source page: https://510kreport.com/device/K003819
Methodology: https://510kreport.com/methodology