510(k) · Cleared
ClearedST/AR ST and Arrhythmia Software Model: Release K.O
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 29, 2010 as substantially equivalent to K080461 (Philips Medical Systems, 2008) and 12 other predicates after a 57-day review. Its family tree reaches back 14 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 29, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 14 generations to K941811 (1994). 136 ancestors in all, the oldest K872781 (1987). 4 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations between
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- 1 generation backK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- This deviceK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · cites it directly · 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 ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
- Descendant · cites it directly · 0 of its ownK150082 Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Show all 14 generations
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 12 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 11 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 10 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 9 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 8 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 7 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 6 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 5 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 4 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
- 1 generation backK080461 Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
- This deviceK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
Most influential descendants
Showing 4 of 4 · See all- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly0descendants
- K151812Patient Monitors Various ModelsPhilips Medical Systems · 2016 · cites it directly0descendants
- K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −13 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −12 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −11 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −10 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −9 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −8 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −7 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −6 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −5 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −4 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K033513 | Easi Ecg Algorithm | Philips Medical Systems | 2004 | — |
| −1 | K080461 | Star ST and Arrhythmia Software, Release J.0 | Philips Medical Systems | 2008 | — |
| 0 (this device) | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +1 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +1 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +1 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
| +1 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 16 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (14)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080461 | Star ST and Arrhythmia Software, Release J.0Summary page 1…itor, Patient Monitor 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Al… | 2008 |
| * | K964122 | HP Star ST and Arrhhythmia SoftwareSummary page 1…t Monitor 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K0… | 1997 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 1…3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the… | 1999 |
| * | K001348 | ST/AR ST and Arrhythmia SoftwareSummary page 1…evice is substantially equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG… | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 1…substantially equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515,… | 2000 |
| * | K014261 | ST/AR ST and Arrhythmia Software, Model Release E.0Summary page 1…ally equivalent to the previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12R… | 2002 |
| * | K021251 | ST/AR ST and Arrhythmia Software, Release E.I. | 2002 |
| * | K033513 | Easi Ecg AlgorithmSummary page 1…previously cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1… | 2004 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…cleared ST/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. a… | 2004 |
| * | K070260 | Star ST and Arrhythmia Software, Release H.0Summary page 1…T/AR ST and Arrhythmnia Software device marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. and the Sie… | 2007 |
| * | K073376 | Philips Ecg AlgorithmSummary page 1…ce marketed pursuant to-K08046 1, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. and the Siemens Infinity MultiView Workstation K030738'… | 2008 |
| Kept off the family tree | K033515 | FDA’s K033515 is Huberpro Safety Huber Infusion Set Our reading of the summary gave K033515, FDA’s number for Huberpro Safety Huber Infusion Set (Command Medical Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips EAST ECG”. Kept off the family tree. Summary page 1…, K(964122, 1K991773, K(001348, K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. and the Siemens Infinity MultiView Workstation K030738' 4. The modification is a s… | 2004 |
| * | K060307 | 12 RL AlgorithmSummary page 1…K003621,, K01426 1, KO02125 1, 1(033513, K(040357. K(070260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. and the Siemens Infinity MultiView Workstation K030738' 4. The modification is a software-based change that adds the follo… | 2006 |
| * | K030738 | Siemens Multiview Infinity Telemetry SystemSummary page 1…0260 and the Philips ECG Algorithm K073376, the Philips EAST ECG K(033515, the GE 12RL Algorithm 1(060307. and the Siemens Infinity MultiView Workstation K030738' 4. The modification is a software-based change that adds the following features: * Support derived 121-lead ECG (… | 2003 |
What descends from it? (4)
4 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 16 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 12 of the 136 ancestors have a recall of any class.
- Of its descendants, K150352 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080461.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
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 EGG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring…
Read the full statement (371 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 EGG 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 arrhythmiar analysis algorithm is to monitor a neonatal, pediatric, or adult patient EGG's for heart rate and ventricular arrhythmias, and produce events/alarms for one or two EGG 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 EGG for ST segment elevation or depression and produce events/alarms for all possible EGG 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 STAR 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 ofarrhythmia. 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.
EASI ECG is intended for monitoring multiple leads of EGG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor EGG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
RLS EGG is intended for monitoring multiple leads of EGG of adults. R.LS EGO is indicated for use by health care professionals whenever there is a need to monitor EGG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101521: ST/AR ST and Arrhythmia Software Model: Release K.O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101521
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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