# K080999: Pagewriter Cardiograph

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: May 9, 2008 after 31 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; 3 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 1.

## Most influential descendants
- K113144: Pagewriter TC 20, 30, 50, 70 (2012), 5 descendants of its own
- K191738: PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (2020), 3 descendants of its own
- K210560: Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (2021), 2 descendants of its own
- K241556: Cardiac Workstation (5000); Cardiac Workstation (7000) (2024), 0 descendants of its own
- K221141: PageWriter TC35 Cardiograph (2022), 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/K080999
Methodology: https://510kreport.com/methodology