# K020708: Philips Pagewriter Touch Cardiograph, Model M5000A Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems, Inc.
- Decided: Apr 25, 2002 after 51 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895520 (1990). 1 ancestor in all.
47 later devices descend from it; 6 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895520: Pagewriter Xli M1700A & Pagewriter XL M1701A, Hewlett-Packard Co. (1990) Summary page 1.

## Most influential descendants
- K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291 (2003), 27 descendants of its own
- 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
- K080999: Pagewriter Cardiograph (2008), 7 descendants of its own

## Recalls of this device
- Sep 12, 2007 · Not classified · Z-0124-2008: Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.
- Oct 13, 2004 · Not classified · Z-0063-05: Software can generate printed ECG's that associate incorrect patient data with the waveform

## 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/K020708
Methodology: https://510kreport.com/methodology