# K110192: Defibrillator Analyzer - DA-2006P

- Pathway: 510(k) (Traditional)
- Applicant: Bc Group International, Inc.
- Decided: Feb 8, 2011 after 15 days
- Product code: DRL (Tester, Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5325
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963190 (1997). 1 ancestor in all.
1 later device descends 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)
- K963190: QA-40M Defibrillator Tester, Metron U.S., Inc. (1997) Summary page 1.

## Most influential descendants
- K190437: Delta 3300 (2019), 0 descendants of its own

## Recalls of this device
- Oct 28, 2015 · Class III · Z-0457-2016: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

## Indications for use
The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.

Source page: https://510kreport.com/device/K110192
Methodology: https://510kreport.com/methodology