510(k) · Cleared

Cleared

Defibrillator Cable Tester, Model DT2200

K061606510(k) TraditionalCleared Jun 21, 200612-day reviewClass II21 CFR 870.2910

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

Medical Devices/Padpro, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Jun 21, 2006 as substantially equivalent to K790394 (Physio-Control Corp., 1979) after a 12-day review. Its family tree reaches back 1 generation to 1979.

Decided: Jun 21, 2006
Review: 12 days
Class: Class II
Product code: DRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K790394 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK790394 Defibrillator Interal Paddle Test LoadPhysio-Control Corp. · 1979
This deviceK061606 Defibrillator Cable Tester, Model DT2200Medical Devices/Padpro, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K790394	Defibrillator Interal Paddle Test Load	Physio-Control Corp.	1979	—
0 (this device)	K061606	Defibrillator Cable Tester, Model DT2200	Medical Devices/Padpro, Inc.	2006	—

FIG. 1 — Lineage of K061606, 1979–2006Source: 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 DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DRG device

#1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K790394	Defibrillator Interal Paddle Test Load Summary page 1 …Defibrillator Test Load 2. Equivalent legally marketed device: This device identical in function and similar in design to the Physio-control Defibrillator Test Load, K790394. 3. Indications for Use: This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators. 4. D…	Physio-Control Corp.	1979	—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRG

3in 2025

2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DRG

52in 2025

2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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	6	63	3	14
2008	5	74	0	9
2009	13	94	0	5
2010	10	68	0	13
2011	9	104	0	12
2012	12	103	0	9
2013	13	146	0	13
2014	10	177	0	97
2015	2	—	0	131
2016	2	—	0	182
2017	7	98	0	484
2018	6	220	0	166
2019	5	122	0	70
2020	6	159	0	82
2021	2	—	0	107
2022	6	287	0	43
2023	4	212	0	19
2024	3	125	0	26
2025	3	127	0	52
2026	2	—	1	—

What is it indicated for?

This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061606: Defibrillator Cable Tester, Model DT2200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061606

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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