# K091696: Savi Wireless, Model PM500

- Pathway: 510(k) (Special)
- Applicant: Medicomp, Inc.
- Decided: Oct 26, 2009 after 138 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: 2 generations back to K981119 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K161916: TelePatch Cardiac Monitor (2016), 0 descendants of its own

## Indications for use
The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. 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/K091696
Methodology: https://510kreport.com/methodology