510(k) · Cleared
ClearedST/AR ST and Arrhythmia Software, Release E.I.
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 May 7, 2002 as substantially equivalent to K964122 (Hewlett-Packard Co., 1997) and 4 other predicates after an 18-day review. Its family tree reaches back 3 generations to 1997. 262 later devices descend from it.
- Decided
- May 7, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K964122 (1997). 7 ancestors in all. 262 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK964122 HP Star ST and Arrhhythmia SoftwareHewlett-Packard Co. · 1997
- 2 generations backK991773 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 1 generation backK014261 ST/AR ST and Arrhythmia Software, Model Release E.0Philips Medical Systems, Inc. · 2002
- This deviceK021251 ST/AR ST and Arrhythmia Software, Release E.I.Philips Medical Systems · 2002
- Descendant · cites it directly · 260 of its ownK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · 2 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- Descendant · 2 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 262 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 262 · See all- K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc. · 2004 · cites it directly260descendants
- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 2 generations on252descendants
- K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 2 generations on251descendants
- K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on250descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964122 | HP Star ST and Arrhhythmia Software | Hewlett-Packard Co. | 1997 | — |
| −2 | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −1 | K014261 | ST/AR ST and Arrhythmia Software, Model Release E.0 | Philips Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K021251 | ST/AR ST and Arrhythmia Software, Release E.I. | Philips Medical Systems | 2002 | — |
| +1 | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A… | Philips Medical Systems, Inc. | 2004 | — |
| +2 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +2 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| +2 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +2 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 8 | 0 |
| 2016 | 13 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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? (5)
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…Physiological Monitor, Patient Monitor The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621 and K014261. The modification is a software-based change that provides Cardiotach functionality witho… | 1997 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 1…ical Monitor, Patient Monitor The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621 and K014261. The modification is a software-based change that provides Cardiotach functionality without arrhyt… | 1999 |
| * | K001348 | ST/AR ST and Arrhythmia SoftwareSummary page 1…tor, Patient Monitor The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621 and K014261. The modification is a software-based change that provides Cardiotach functionality without arrhythmia anal… | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 1…ent Monitor The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621 and K014261. The modification is a software-based change that provides Cardiotach functionality without arrhythmia analysis and… | 2000 |
| * | K014261 | ST/AR ST and Arrhythmia Software, Model Release E.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, K001348, K003621 and K014261. The modification is a software-based change that provides Cardiotach functionality without arrhythmia analysis and ST Segment A… | 2002 |
What descends from it? (262)
See all 2624 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry… | 2004 | 260 |
| K070260 | Star ST and Arrhythmia Software, Release H.0 | 2007 | 7 |
| K080461 | Star ST and Arrhythmia Software, Release J.0 | 2008 | 6 |
| 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 5 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K040357 (Philips Medical Systems, Inc., 2004) has gone furthest, with 260 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.
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 (180 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021251: ST/AR ST and Arrhythmia Software, Release E.I..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021251
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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