# K091548: Amco Replacement Battery for Philips Medical Models BT1 and M5070A

- Pathway: 510(k) (Traditional)
- Applicant: Amco International Manufacturing & Design, Inc.
- Decided: Aug 7, 2009 after 72 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: 2 generations back to K003565 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955628: Fore Runner External Defibrillator/Defibrillator Pads, Heartstream, Inc. (1996) Summary page 1.
- K020715: Philips M5066A and M5068A, Philips Medical Systems (2002) Summary page 1.
- K040904: Philips Heartstart Home Defibrillator, Model M5068A, Philips Medical Systems (2004) Summary page 1.
- K050004: Philips Heartstart FRX Defibrillator, Model 861304, Philips Medical Systems (2005) Summary page 1.

## Indications for use
The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture. The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical I HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.

Source page: https://510kreport.com/device/K091548
Methodology: https://510kreport.com/methodology