510(k) · Cleared
ClearedPhilips DXL 12/16-Lead Ecg Algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DPS Electrocardiograph
Cleared on Sep 26, 2013 as substantially equivalent to K020708 (Philips Medical Systems, Inc., 2002) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Sep 26, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895520 (1990). No later device cites it as a predicate yet.
- 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 backK052049 Philips 12-Lead AlgorithmPhilips Medical Systems · 2005
- This deviceK132068 Philips DXL 12/16-Lead Ecg AlgorithmPhilips Medical Systems · 2013
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 | K052049 | Philips 12-Lead Algorithm | Philips Medical Systems | 2005 | — |
| 0 (this device) | K132068 | Philips DXL 12/16-Lead Ecg Algorithm | Philips Medical Systems | 2013 | — |
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? (2)
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…870.2340,11 74 DPS Electrocardiograph The new device is substantially equivalent to the previously cleared Philips ECG Algorithm software cleared under K020708 and K052049. The Philips DXL 12/16-lead ECG Algorithm provides an analysis of the amplitudes, durations, electrical axis, and mo… | 2002 |
| * | K052049 | Philips 12-Lead AlgorithmSummary page 1…2340,11 74 DPS Electrocardiograph The new device is substantially equivalent to the previously cleared Philips ECG Algorithm software cleared under K020708 and K052049. The Philips DXL 12/16-lead ECG Algorithm provides an analysis of the amplitudes, durations, electrical axis, and morphologies o… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 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. 2013, 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 analyze multi-channel ECG signals from adult and pediatric patients 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…
Read the full statement (119 words)
To analyze multi-channel ECG signals from adult and pediatric patients 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.
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/K132068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132068: Philips DXL 12/16-Lead Ecg Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132068
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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