# K043454: Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410

- Pathway: 510(k) (Special)
- Applicant: Medicomp, Inc.
- Decided: Mar 24, 2005 after 99 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981119 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K981119: Cardiopal Model Number PM20, Medicomp, Inc. (1998)

## Most influential descendants
- 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 Al with Diogenes SV (CardioPal SV) Model PM410, 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/K043454
Methodology: https://510kreport.com/methodology