510(k) · Cleared
ClearedOB Tracevue Obstetrical Information Management System with Release F.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 May 28, 2008 as substantially equivalent to K970456 (Hewlett-Packard GmbH, 1997) after a 30-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970456 (1997). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970456 Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and…Hewlett-Packard GmbH · 1997
- This deviceK081203 OB Tracevue Obstetrical Information Management System with Release…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · cites it directly · 4 of its ownK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
- Descendant · 2 generations on · 1 of its ownK173941 IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018
- Descendant · cites it directly · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK111083 Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK220732 Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · cites it directly4descendants
- K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH · 2018 · 2 generations on1descendant
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · cites it directly1descendant
- K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on1descendant
- K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving… | Hewlett-Packard GmbH | 1997 | — |
| 0 (this device) | K081203 | OB Tracevue Obstetrical Information Management System with Release F.00 | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +1 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
| +2 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| +1 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +2 | K111083 | Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 1 |
| +3 | K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving SystemSummary page 1…HGM anaccessories Monitoring Devices 3. The modified device is substantially equivalent to the previously cleared Philips devices marketed pursuant to K970456. 4. The modification is the introduction of Revision F.00 software for the Philips OB TraceVue Rev.F.00 Obstetrical Infor… | 1997 |
What descends from it? (7)
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?
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OB TraceVue Obstetrical Information Management System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive obstetrical surveillance of patients at central station, all bedsides, nurses' lounges, physicians' lounges and offices. The Philips OB TraceVue Obstetrical Information Management System allows easy-to-use patient surveillance in hospitals. It is easy to expand and the…
Read the full statement (158 words)
The Philips OB TraceVue Obstetrical Information Management System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive obstetrical surveillance of patients at central station, all bedsides, nurses' lounges, physicians' lounges and offices.
The Philips OB TraceVue Obstetrical Information Management System allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alarming and optional storage.
The specific medical indication for use of this device is:
* This device is a prescription device.
* This device is not intended to contact the patient.
* This device is used continuously in Obstetrical / Gynecological departments (OB/GYN).
* Basic and advanced fetal trace alarming for both antepartum /and intrapartum applications.
* The physiological purpose is indirect. The device is intended to gather and store patient information and to document relevant monitor information (surveillance) of patients in OB and GYN, as needed by care providers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081203 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081203: OB Tracevue Obstetrical Information Management System with Release F.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081203
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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