510(k) · Cleared
ClearedPhillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 18, 2002 as substantially equivalent to K003038 (Agilent Technologies Deutschland GmbH, 2000) and 5 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1994. 253 later devices descend from it.
- Decided
- Jan 18, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K941811 (1994). 14 ancestors in all, the oldest K903771 (1991). 253 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 3 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 2 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 1 generation backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- This deviceK014159 Phillips M1175A/76A/77A Component Monitoring System; Phillips…Philips Medical Systems, Inc. · 2002
- Descendant · cites it directly · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · cites it directly · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- Descendant · cites it directly · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · cites it directly · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · cites it directly · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 253 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 253 · See all- K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · cites it directly252descendants
- K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · cites it directly251descendants
- K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly250descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly247descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −3 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −2 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −1 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K014159 | Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient… | Philips Medical Systems, Inc. | 2002 | — |
| +1 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +1 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| +1 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +1 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +1 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 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? (6)
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 |
|---|---|---|---|
| * | K003038 | Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model…Summary page 2…Monitors Panel 80 880.2910, II FLL Thermometer, electronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subc… | 2000 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 2…Panel 80 880.2910, II FLL Thermometer, electronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subclause 4.4… | 2000 |
| * | K990125 | HP Viridia Component Monitoring System, Model Rev. KSummary page 2…880.2910, II FLL Thermometer, electronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subclause 4.4.2.1 of A… | 1999 |
| * | K981576 | Multi-Parameter Module, Model M3000A & Display Unit, Model M3046ASummary page 2…II FLL Thermometer, electronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10… | 1998 |
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 2…hermometer, electronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10 for pedi… | 1998 |
| * | K903771 | HP Model M1008B, Noninvasive Blood Pressure ModuleSummary page 2…ectronic, General clinical Hospital The new devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771 The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adul… | 1991 |
What descends from it? (253)
See all 25310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | 2004 | 252 |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors | 2004 | 251 |
| K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors | 2005 | 250 |
| K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 | 2005 | 249 |
| K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors | 2005 | 247 |
| K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60… | 2005 | 234 |
| K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 | 2006 | 233 |
| K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient… | 2006 | 222 |
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors | 2006 | 221 |
| K052961 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors… | 2005 | 180 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K041235 (Philips Medizin Systeme Boeblingen GmbH, 2004) has gone furthest, with 252 descendants of its own.
- 1 other device also cites its predicate K003038.
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?
Intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
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/K014159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014159: Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014159
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026