510(k) · Cleared
Recalled · Class II · 2019Pagewriter TC 20, 30, 50, 70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DPS Electrocardiograph
Cleared on Apr 3, 2012 as substantially equivalent to K080999 (Philips Medical Systems, 2008) after a 161-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it. It has been recalled 9 times.
- Decided
- Apr 3, 2012
- Review
- 161 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895520 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 2 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK080999 Pagewriter CardiographPhilips Medical Systems · 2008
- This deviceK113144 Pagewriter TC 20, 30, 50, 70Philips Medical Systems · 2012
- Descendant · cites it directly · 3 of its ownK191738 PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter…Philips Medical Systems · 2020
- Descendant · 2 generations on · 2 of its ownK210560 Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page…Philips Medical Systems · 2021
- Descendant · 3 generations on · 0 of its ownK241556 Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK221141 PageWriter TC35 CardiographMedizin Systeme Boblingen GmbH · 2022
- Descendant · cites it directly · 0 of its ownK152135 Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…Philips Medical Systems · 2020 · cites it directly3descendants
- K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…Philips Medical Systems · 2021 · 2 generations on2descendants
- K241556Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH · 2024 · 3 generations on0descendants
- K221141PageWriter TC35 CardiographMedizin Systeme Boblingen GmbH · 2022 · 3 generations on0descendants
- K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −2 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −1 | K080999 | Pagewriter Cardiograph | Philips Medical Systems | 2008 | — |
| 0 (this device) | K113144 | Pagewriter TC 20, 30, 50, 70 | Philips Medical Systems | 2012 | — |
| +1 | K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50… | Philips Medical Systems | 2020 | — |
| +2 | K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50… | Philips Medical Systems | 2021 | — |
| +3 | K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | 2024 | 4 |
| +3 | K221141 | PageWriter TC35 Cardiograph | Medizin Systeme Boblingen GmbH | 2022 | — |
| +1 | K152135 | Quantitative Electrocardiographic Detector (QED 2000) | Acme Portable Machines, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080999 | Pagewriter CardiographSummary page 3…Comparison Model (New Device) (Predicate) K080999 Page 3 of 8 510(K) S… | 2008 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2019 | Class II | Z-0853-2019 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191738 (Philips Medical Systems, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K080999.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
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…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113144: Pagewriter TC 20, 30, 50, 70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113144
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026