510(k) · Cleared
ClearedPagewriter Cardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DPS Electrocardiograph
Cleared on May 9, 2008 as substantially equivalent to K020708 (Philips Medical Systems, Inc., 2002) after a 31-day review. Its family tree reaches back 2 generations to 1990. 7 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895520 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 1 generation backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- This deviceK080999 Pagewriter CardiographPhilips Medical Systems · 2008
- Descendant · cites it directly · 5 of its ownK113144 Pagewriter TC 20, 30, 50, 70Philips Medical Systems · 2012 · Recalled
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113144Pagewriter TC 20, 30, 50, 70Philips Medical Systems · 2012 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −1 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| 0 (this device) | K080999 | Pagewriter Cardiograph | Philips Medical Systems | 2008 | — |
| +1 | K113144 | Pagewriter TC 20, 30, 50, 70 | Philips Medical Systems | 2012 | 9 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A SeriesSummary page 1…74 DPS Electrocardiograph 3. The new device is substantially equivalent to the previously cleared Philips cardiograph cleared under K020708. 4. The modification provides the following additional capabilities: improved ease of use ( 3 step ECG), improved h… | 2002 |
What descends from it? (7)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K113144 (Philips Medical Systems, 2012) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K020708.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080999 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080999: Pagewriter Cardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080999
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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