510(k) · Cleared
ClearedStar ST and Arrhythmia Software, Release J.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MLD Monitor, St Segment With Alarm
Cleared on Mar 13, 2008 as substantially equivalent to K964122 (Hewlett-Packard Co., 1997) and 10 other predicates after a 22-day review. Its family tree reaches back 13 generations to 1994. 6 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- MLD
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 13 generations to K941811 (1994). 101 ancestors in all, the oldest K872781 (1987). 6 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations between
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- This deviceK080461 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 · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
Show all 13 generations
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- This deviceK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation · 2016 · cites it directly0descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −12 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −11 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −10 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −9 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −8 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −7 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −6 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −5 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −4 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −3 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −1 | K033513 | Easi Ecg Algorithm | Philips Medical Systems | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
| +2 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 13 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MLD? 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? (11)
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…Monitor, 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, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-P… | 1997 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 1…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, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhyt… | 1999 |
| * | K001348 | ST/AR ST and Arrhythmia SoftwareSummary page 1…onitor 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Dete… | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 1…he new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm… | 2000 |
| * | K014261 | ST/AR ST and Arrhythmia Software, Model Release E.0Summary page 1…vice is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320.… | 2002 |
| * | K021251 | ST/AR ST and Arrhythmia Software, Release E.I.Summary page 1…ubstantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. T… | 2002 |
| * | K033513 | Easi Ecg AlgorithmSummary page 1…lly equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. The modifi… | 2004 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…alent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. The modification is… | 2004 |
| * | K070260 | Star ST and Arrhythmia Software, Release H.0Summary page 1…the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. The modification is a softwa… | 2007 |
| * | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesSummary page 1…Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. The modification is a software-based change that adds the following… | 2008 |
| * | K031320 | EK-Pro Arrhythmia Detection AlgorithmSummary page 1…964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320. 4. The modification is a software-based change that adds the following features: - Atrial Fibrillation alarm… | 2003 |
What descends from it? (6)
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 14 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 11 of the 101 ancestors have a recall of any class.
- Of its descendants, K101521 (Philips Medical Systems, 2010) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K964122.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MLD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MLD
Too few MLD 510(k)s in any year since 2007 to give a median.
Recalls per year · MLD
No recall names MLD since 2007.
Adverse event reports per year · MLD
1in 2019
MAUDE reports naming product code MLD, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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/K080461 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080461: Star ST and Arrhythmia Software, Release J.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080461
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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