510(k) · Cleared
ClearedPhilips Ecg Algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · LOS (no longer in FDA’s product-code list)
Cleared on Apr 11, 2008 as substantially equivalent to K020708 (Philips Medical Systems, Inc., 2002) and 1 other predicate after a 130-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 130 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895520 (1990). 5 later devices descend from it, 1 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 backK052049 Philips 12-Lead AlgorithmPhilips Medical Systems · 2005
- This deviceK073376 Philips Ecg AlgorithmPhilips Medical Systems · 2008
- Descendant · cites it directly · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 2 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
- Descendant · 2 generations on · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · cites it directly4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
- K151812Patient Monitors Various ModelsPhilips Medical Systems · 2016 · 2 generations on0descendants
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on0descendants
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) | K073376 | Philips Ecg Algorithm | Philips Medical Systems | 2008 | — |
| +1 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +2 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +2 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
| +2 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…Electrocardiograph 3. The new device is substantially equivalent to the previously cleared Philips 12-Lead ECG Algorithm software cleared under K020708 and K052049. 4. The modification is a change that provides interpretive analysis capability for additional posterior… | 2002 |
| * | K052049 | Philips 12-Lead AlgorithmSummary page 1…Electrocardiograph 3. The new device is substantially equivalent to the previously cleared Philips 12-Lead ECG Algorithm software cleared under K020708 and K052049. 4. The modification is a change that provides interpretive analysis capability for additional posterior and right s… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | 2010 | 4 |
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 3.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K101521 (Philips Medical Systems, 2010) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K020708.
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/K073376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073376: Philips 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/K073376
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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