# K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems
- Decided: Jul 3, 2003 after 58 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.
27 later devices descend from it; 4 cite it directly.
0 of 30 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)

## Most influential descendants
- K050074: 12-Lead Resting Electrocardiograph, Models CP100 & CP200 (2005), 12 descendants of its own
- K060167: Atria 3100, Atria 6100 (2006), 11 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own
- K072449: CP100 & 200 12-Lead Resting Electrocardiographs (2007), 7 descendants of its own
- K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg (2005), 5 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 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/K031422
Methodology: https://510kreport.com/methodology