510(k) · Cleared
ClearedPhilips Obtracevue Model SW Rev. G.00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · HGM System, Monitoring, Perinatal
Cleared on Jul 26, 2010 as substantially equivalent to K081203 (Philips Medizin Systeme Boeblingen GmbH, 2008) and 3 other predicates after a 160-day review. Its family tree reaches back 21 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 26, 2010
- Review
- 160 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K941811 (1994). 128 ancestors in all, the oldest K872781 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 17 generations between
- 3 generations backK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- 2 generations backK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · Recalled
- 1 generation backK071800 Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · Recalled
- This deviceK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
- Descendant · cites it directly · 1 of its ownK173941 IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018
- Descendant · cites it directly · 1 of its ownK111083 Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK220732 Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK140535 Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH · 2014 · Recalled
Show all 21 generations
- Root · 21 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 20 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 19 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 18 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 17 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 16 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 15 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 14 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 13 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 12 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 11 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 10 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 9 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 8 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 7 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 6 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 5 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 4 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 3 generations backK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- 2 generations backK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · Recalled
- 1 generation backK071800 Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · Recalled
- This deviceK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
Most influential descendants
Showing 4 of 4 · See all- K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018 · cites it directly1descendant
- K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly1descendant
- K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on0descendants
- K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −20 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −19 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −18 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −17 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −16 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −15 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −14 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −13 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −12 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −11 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −10 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −9 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −8 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −7 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −6 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −5 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −4 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −3 | K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2005 | 1 |
| −2 | K062137 | Modification to Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2006 | 2 |
| −1 | K071800 | Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | 4 |
| 0 (this device) | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
| +1 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| +1 | K111083 | Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +2 | K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
| +2 | K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizin Systeme Boblingen GmbH | 2014 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 5 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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 HGM? 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 HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K081203 | OB Tracevue Obstetrical Information Management System with Release F.00Summary page 2…is substantially equivalent to the previously cleared Philips OH TraceVue Obstetrical Information Management System Rev. F.OO (K081203, May 2 gth 2008) and the Philips Avalon Fetal Monitors FM2O, FM30, FM4O and… | 2008 |
| * | K071800 | Philips Avalon Fetal Monitors FM20 and FM30Summary page 2…ment System Rev. F.OO (K081203, May 2 gth 2008) and the Philips Avalon Fetal Monitors FM2O, FM30, FM4O and FM5O K071800 (September 2 7 th 2007) and the Philips M3290A Intellivue Information Center Software R… | 2007 |
| * | K031403 | M3290A Intellivue Information Center Software Release E.1Summary page 2…O K071800 (September 2 7 th 2007) and the Philips M3290A Intellivue Information Center Software Release E.l K(031403 (May 3 0oth 2003) and Software release G.OO K(050742 (April 0 5 th 2005) 5.3 The modifications of… | 2003 |
| * | K050742 | M3290A Intellivue Information Center Software Release G.00Summary page 2…hilips M3290A Intellivue Information Center Software Release E.l K(031403 (May 3 0oth 2003) and Software release G.OO K(050742 (April 0 5 th 2005) 5.3 The modifications of the Philips OH TraceVue Modifications Obstetrical Info… | 2005 |
What descends from it? (4)
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 16 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 8 of the 128 ancestors have a recall of any class.
- Of its descendants, K173941 (Philips Medizin Systeme Boeblingen GmbH, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081203.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, 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 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Philips OH TraceVue Obstetrical Information Management System is indicated for obstetric patients during and after pregnancy, who require monitoring in a healthcare setting
The Philips OH Tracevue provides
* Basic and advanced fetal trace alarming for both antepartum and intrapartum patients
* Central monitoring of maternal alarming.
* Documentation capabilities and data storage.
* Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility web access (intra/internet).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100420: Philips Obtracevue Model SW Rev. G.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100420
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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