510(k) · Cleared
ClearedStar ST and Arrhythmia Software, Release H.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 23, 2007 as substantially equivalent to K964122 (Hewlett-Packard Co., 1997) and 6 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.
- Decided
- Feb 23, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K930806 (1994). 13 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 1 generation backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- This deviceK070260 Star ST and Arrhythmia Software, Release H.0Philips Medical Systems · 2007
- Descendant · cites it directly · 6 of its ownK080461 Star ST and Arrhythmia Software, Release J.0Philips 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 ownK152305 Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008 · cites it directly6descendants
- 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
- K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016 · 2 generations on0descendants
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| 0 (this device) | K070260 | Star ST and Arrhythmia Software, Release H.0 | Philips Medical Systems | 2007 | — |
| +1 | K080461 | Star ST and Arrhythmia Software, Release J.0 | 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 | K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016 | — |
| +2 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K964122 | HP Star ST and Arrhhythmia SoftwareSummary page 1…Monior Patient Monitor 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, KOO01348, K003621, KOl 4261 and K02 1251 and the Philips 2010 Plus Hotter for Windows KOl 0949. 4. The mod… | 1997 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 1…atient Monitor 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, KOO01348, K003621, KOl 4261 and K02 1251 and the Philips 2010 Plus Hotter for Windows KOl 0949. 4. The modification… | 1999 |
| * | K001348 | ST/AR ST and Arrhythmia Software | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 1…The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, KOO01348, K003621, KOl 4261 and K02 1251 and the Philips 2010 Plus Hotter for Windows KOl 0949. 4. The modification is a software-base… | 2000 |
| * | K014261 | ST/AR ST and Arrhythmia Software, Model Release E.0 | 2002 |
| * | K021251 | ST/AR ST and Arrhythmia Software, Release E.I.Summary page 1…ntially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, KOO01348, K003621, KOl 4261 and K02 1251 and the Philips 2010 Plus Hotter for Windows KOl 0949. 4. The modification is a software-based change that adds QT/QTc inte… | 2002 |
| * | K010949 | 2010 Plus Holter for Windows | 2001 |
What descends from it? (7)
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)
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 13 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K080461 (Philips Medical Systems, 2008) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K964122.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring…
Read the full statement (251 words)
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.
Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070260: Star ST and Arrhythmia Software, Release H.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070260
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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