510(k) · Cleared

Cleared

TelePatch Cardiac Monitor

K161916510(k) TraditionalCleared Dec 21, 2016162-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

Medicomp, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Dec 21, 2016 as substantially equivalent to K043454 (Medicomp, Inc., 2005) and 1 other predicate after a 162-day review. Its family tree reaches back 3 generations to 1998.

Decided: Dec 21, 2016
Review: 162 days
Class: Class II
Product code: DRG
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K981119 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK981119 Cardiopal Model Number PM20Medicomp, Inc. · 1998
2 generations backK043454 Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Medicomp, Inc. · 2005
1 generation backK091696 Savi Wireless, Model PM500Medicomp, Inc. · 2009
This deviceK161916 TelePatch Cardiac MonitorMedicomp, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K981119	Cardiopal Model Number PM20	Medicomp, Inc.	1998	—
−2	K043454	Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410	Medicomp, Inc.	2005	—
−1	K091696	Savi Wireless, Model PM500	Medicomp, Inc.	2009	—
0 (this device)	K161916	TelePatch Cardiac Monitor	Medicomp, Inc.	2016	—

FIG. 1 — Lineage of K161916, 1998–2016Source: 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? (2)

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
*	K043454	Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 Summary page 5 …O Page 1 of 7 K161916 4. Predicate Device Information: K#043454, CardioPAL SAVI (Model PM410) Event /Loop Recorder, Medicomp Inc., K#091696, SAVI Wireless (Model PM500) Radiofrequency Phys…	Medicomp, Inc.	2005	—
*	K091696	Savi Wireless, Model PM500 Summary page 5 …K161916 4. Predicate Device Information: K#043454, CardioPAL SAVI (Model PM410) Event /Loop Recorder, Medicomp Inc., K#091696, SAVI Wireless (Model PM500) Radiofrequency Physiological Signal Transmitter and Receiver, Medicomp, Inc. 5. Device Desc…	Medicomp, Inc.	2009	—

Also cleared against K043454: 1 other device →

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?

The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 6.4 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K043454.

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. 2016, this device’s year, is highlighted.

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?

The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161916 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161916: TelePatch Cardiac Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161916

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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