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Replacement Battery for Philips Medical Models BT1 and M5070A

FDA 510(k)

Class III (US FDA 510(k))

510(k) K091548

by Amco International Manufacturing & Design, Inc.

Identifiers

510(k) Number
K091548 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Replacement Battery for Automated External Defibrillators (Non-Wearable), designed to provide power to Philips Medical defibrillator models BT1 and M5070A. It serves as a critical component for maintaining operational readiness in emergency cardiac arrest scenarios by ensuring uninterrupted functionality of the defibrillator’s battery-dependent features.

The battery is supplied as a standalone unit, intended for single-use replacement within compatible Philips Medical defibrillators. It is classified as a Class III medical device under FDA regulations (870.5310) and holds an FDA 510(k) clearance (K091548) as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided, and storage conditions are not detailed in the regulatory submission.

Frequently asked questions

What Philips Medical defibrillator models is this replacement battery designed for, and how do I confirm compatibility with my device?

This replacement battery is specifically designed for Philips Medical defibrillator models BT1 and M5070A. To confirm compatibility, check your device’s model number against the manufacturer’s specifications or consult Philips Medical’s technical documentation. Since this is a standalone replacement, it should only be used in the exact models listed to ensure proper functionality and safety.

Is this battery single-use or reusable, and what happens if I try to reuse it?

This battery is intended for single-use replacement only within compatible Philips Medical defibrillators. Reusing it is not supported by the manufacturer, as it may compromise performance, safety, or reliability during critical emergency scenarios. Always follow the manufacturer’s instructions to replace it with a new unit when needed.

Are there any special storage requirements for this replacement battery before installation?

The regulatory submission does not specify storage conditions for this battery. However, as with most medical batteries, it should be stored in a cool, dry place, away from direct sunlight or extreme temperatures, to maintain its integrity until use. Always check the manufacturer’s latest guidelines for any updates.

What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?

This battery holds an FDA 510(k) clearance (K091548) under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class III medical device (device code MKJ, category Automated External Defibrillators (Non-Wearable)). Clinicians can rely on this clearance as evidence of regulatory review, though local institutional protocols should still govern its procurement and use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Amco International Manufacturing & Design, Inc.

Sources (1)

  • FDA 510(k) K091548 24 fields · synced Sep 18, 2026