# K161916: TelePatch Cardiac Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Medicomp, Inc.
- Decided: Dec 21, 2016 after 162 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981119 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043454: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410, Medicomp, Inc. (2005) Summary page 5.
- K091696: Savi Wireless, Model PM500, Medicomp, Inc. (2009) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K161916
Methodology: https://510kreport.com/methodology