# K113144: Pagewriter TC 20, 30, 50, 70

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Apr 3, 2012 after 161 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 9 (0 Class I)
- 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; 2 cite 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)
- K080999: Pagewriter Cardiograph, Philips Medical Systems (2008) Summary page 3.

## Most influential descendants
- 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
- K152135: Quantitative Electrocardiographic Detector (QED 2000) (2016), 0 descendants of its own

## Recalls of this device
- Jan 9, 2019 · Class II · Z-0853-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0854-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0855-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0859-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0856-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0857-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0860-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0858-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
- Jan 9, 2019 · Class II · Z-0861-2019: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

## Indications for use
To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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 over read and validate (or change) the computer generated ECG interpretation.

Source page: https://510kreport.com/device/K113144
Methodology: https://510kreport.com/methodology