# K963190: QA-40M Defibrillator Tester

- Pathway: 510(k) (Traditional)
- Applicant: Metron U.S., Inc.
- Decided: Jul 1, 1997 after 320 days
- Product code: DRL (Tester, Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110192: Defibrillator Analyzer - DA-2006P (2011), 1 descendant of its own
- K190437: Delta 3300 (2019), 0 descendants of its own

## Indications for use
The Metron U.S. Q4-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements. The QA4-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The Q4-40M test for ANSI/AAMI DF39 standards. The QA4-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the QA-40M contact plates. Thus, the defibrillator is connected through load resistance. When the defibrillator is discharged, Q4-40M will calculate and display the energy delivered. The QA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform, (4) 12 lead ECG simulation. (§) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.

Source page: https://510kreport.com/device/K963190
Methodology: https://510kreport.com/methodology