510(k) · Cleared

Recalled · Class III · 2015

Defibrillator Analyzer - DA-2006P

K110192510(k) TraditionalCleared Feb 8, 201115-day reviewClass II21 CFR 870.5325Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bc Group International, Inc. · DRL Tester, Defibrillator

Cleared on Feb 8, 2011 as substantially equivalent to K963190 (Metron U.S., Inc., 1997) after a 15-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.

Decided: Feb 8, 2011
Review: 15 days
Class: Class II
Product code: DRL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K963190 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK963190 QA-40M Defibrillator TesterMetron U.S., Inc. · 1997
This deviceK110192 Defibrillator Analyzer - DA-2006PBc Group International, Inc. · 2011
Descendant · cites it directly · 0 of its ownK190437 Delta 3300Netech Corporation · 2019

Most influential descendants

Showing 1 of 1 · See all

K190437Delta 3300Netech Corporation · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963190	QA-40M Defibrillator Tester	Metron U.S., Inc.	1997	—
0 (this device)	K110192	Defibrillator Analyzer - DA-2006P	Bc Group International, Inc.	2011	—
+1	K190437	Delta 3300	Netech Corporation	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K110192, 1997–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K963190	QA-40M Defibrillator Tester Summary page 1 …Class Class 11/21CFR 870.5325 Product Code DRL Predicate Devices *Metron QA-40/45M Defibrillator Tester (K(963190) 5.1 BC Group International, Inc. Section 514 Compliance…	Metron U.S., Inc.	1997	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K190437	Delta 3300	Netech Corporation	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 28, 2015	Class III	Z-0457-2016	Employee error	Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K190437 (Netech Corporation, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRL devices

DRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DRL

1in 2019

2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRL

Too few DRL 510(k)s in any year since 2007 to give a median.

Recalls per year · DRL

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRL

2in 2013

2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code DRL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	2	—	0	0
2009	0	—	0	1
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	0	—	0	2
2014	0	—	0	0
2015	1	—	1	0
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110192 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110192: Defibrillator Analyzer - DA-2006P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110192

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026