510(k) · Cleared
ClearedPhilips Heartstart 12 Lead Transfer Station, Model 989803142521
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 7, 2007 as substantially equivalent to K032103 (Philips Medical Systems, 2003) after a 112-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Sep 7, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K840932 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK840932 Muse-DPMarquette Electronics, Inc. · 1984
- 2 generations backK974420 M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B…Hewlett-Packard Co. · 1998
- 1 generation backK032103 Philips Tracemaster Ecg Management System, Models M5100A and M5101APhilips Medical Systems · 2003
- This deviceK071391 Philips Heartstart 12 Lead Transfer Station, Model 989803142521Philips Medical Systems, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840932 | Muse-DP | Marquette Electronics, Inc. | 1984 | — |
| −2 | K974420 | M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit… | Hewlett-Packard Co. | 1998 | — |
| −1 | K032103 | Philips Tracemaster Ecg Management System, Models M5100A and M5101A | Philips Medical Systems | 2003 | — |
| 0 (this device) | K071391 | Philips Heartstart 12 Lead Transfer Station, Model 989803142521 | Philips Medical Systems, Inc. | 2007 | — |
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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K032103 | Philips Tracemaster Ecg Management System, Models M5100A and M5101ASummary page 2…KtJ i~qJ 4. The new device is substantially equivalent to the previously cleared M5100A TraceMasterVue ECG Management System cleared under K032103. 5. The product has a similar clinical intended use as the legally marketed predicate device. The only difference is that t… | 2003 |
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 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K032103.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system.
The HeartStart 12 Lead Transfer Station application also allows viewing, printing, archiving and further distribution of digitized ECG records.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071391: Philips Heartstart 12 Lead Transfer Station, Model 989803142521.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071391
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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