# K981119: Cardiopal Model Number PM20

- Pathway: 510(k) (Traditional)
- Applicant: Medicomp, Inc.
- Decided: Oct 14, 1998 after 201 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K043454: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 (2005), 2 descendants of its own
- K091696: Savi Wireless, Model PM500 (2009), 1 descendant of its own
- K161916: TelePatch Cardiac Monitor (2016), 0 descendants of its own

## Indications for use
The CardioPAL 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. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.

Source page: https://510kreport.com/device/K981119
Methodology: https://510kreport.com/methodology