510(k) · Cleared
Recalled · 2009Modification to Philips Avalon Fetal Monitors FM20 and FM30
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 Aug 24, 2006 as substantially equivalent to K052795 (Philips Medizin Systeme Boeblingen GmbH, 2005) after a 29-day review. Its family tree reaches back 19 generations to 1994. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 24, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 19 generations to K941811 (1994). 124 ancestors in all, the oldest K872781 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 15 generations between
- 3 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 1 generation backK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- This deviceK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · cites it directly · 7 of its ownK071800 Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
- Descendant · cites it directly · 3 of its ownK092028 Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010
- Descendant · 2 generations on · 2 of its ownK102958 Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH · 2011
- Descendant · 3 generations on · 1 of its ownK173941 IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018
Show all 19 generations
- Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 18 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 17 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 16 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 15 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 14 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 13 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 12 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 11 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 10 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 9 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 8 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 7 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 6 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 5 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 4 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 3 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 1 generation backK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- This deviceK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly7descendants
- K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · 2 generations on4descendants
- K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010 · cites it directly3descendants
- K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH · 2011 · 2 generations on2descendants
- K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −18 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −17 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −16 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −15 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −14 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −13 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −12 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −11 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −10 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −9 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −8 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −7 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −6 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −5 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −4 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −3 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −2 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −1 | K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2005 | 1 |
| 0 (this device) | K062137 | Modification to Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +1 | K071800 | Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | 4 |
| +2 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
| +1 | K092028 | Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
| +2 | K102958 | Philips Avalon Fetal Monitor | Philips Medizin Systeme Boblingen GmbH | 2011 | — |
| +3 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30Summary page 2…l Monitors FM20 and FM30 are substantially equivalent to previously cleared Philips Avalon Fetal Monitors FM20 and FM30 marketed pursuant to K052795. 4. The modification of the Philips Avalon Fetal Monitors FM20 and FM30 introduces the capability of monitoring fetal heart r… | 2005 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2009 | Not classified | Z-0549-2010 | Process design | Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate… |
| Nov 23, 2009 | Not classified | Z-0550-2010 | Process design | Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 6 of the 124 ancestors have a recall of any class.
- Of its descendants, K071800 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2007) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K052795.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal Monitor FM20: Indicated for use by trained health…
Read the full statement (116 words)
Avalon Fetal Monitor FM30:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Avalon Fetal Monitor FM20:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062137
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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