# K073376: Philips Ecg Algorithm

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Apr 11, 2008 after 130 days
- Product code: LOS
- 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 K895520 (1990). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020708: Philips Pagewriter Touch Cardiograph, Model M5000A Series, Philips Medical Systems, Inc. (2002) Summary page 1.
- K052049: Philips 12-Lead Algorithm, Philips Medical Systems (2005) Summary page 1.

## Most influential descendants
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own
- K151812: Patient Monitors Various Models (2016), 0 descendants of its own
- K150082: Panorama Patient Monitoring Network (2015), 0 descendants of its own

## Indications for use
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Source page: https://510kreport.com/device/K073376
Methodology: https://510kreport.com/methodology