# K052049: Philips 12-Lead Algorithm

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Aug 26, 2005 after 28 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K895520 (1990). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 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 2.

## Most influential descendants
- K073376: Philips Ecg Algorithm (2008), 5 descendants of its own
- 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

## Indications for use
To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer generated ECG interpretation. 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/K052049
Methodology: https://510kreport.com/methodology