510(k) · Cleared
ClearedHewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard GmbH · HGM System, Monitoring, Perinatal
Cleared on Oct 3, 1997 after a 239-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Oct 3, 1997
- Review
- 239 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK970456 Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and…Hewlett-Packard GmbH · 1997
- Descendant · cites it directly · 9 of its ownK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · Recalled
- Descendant · cites it directly · 7 of its ownK081203 OB Tracevue Obstetrical Information Management System with Release…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · 2 generations on · 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly9descendants
- K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on8descendants
- K081203OB Tracevue Obstetrical Information Management System with Release F.00Philips Medizin Systeme Boeblingen GmbH · 2008 · cites it directly7descendants
- K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on7descendants
- K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving… | Hewlett-Packard GmbH | 1997 | — |
| +1 | 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 | K081203 | OB Tracevue Obstetrical Information Management System with Release F.00 | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | — | HP Obstetrical Information Management System 80235B Named without a submission number | |
| * | — | HP Obstetrical Information Management System M1370A Named without a submission number |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | 2005 | 9 |
| K081203 | OB Tracevue Obstetrical Information Management System with Release F.00 | 2008 | 7 |
| K974248 | Watchchild Obsterical Patient Data Management System | 1998 | 2 |
| K040788 | Calm Patterns, Version 01.00.00 | 2005 | 1 |
| K060230 | Dopplex Centrale | 2006 | 0 |
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?
- Of its descendants, K052795 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 9 descendants of its own.
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?
The HP Series 50 OB TraceVue is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive obstetrical surveillance of up to 30 patients at central station, all bedsides, nurses’ lounges, physicians’ lounges and offices. The HP Series S0 OB TraceVue allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum…
Read the full statement (151 words)
The HP Series 50 OB TraceVue is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive obstetrical surveillance of up to 30 patients at central station, all bedsides, nurses’ lounges, physicians’ lounges and offices.
The HP Series S0 OB TraceVue allows easy-to-use patient surveillance in hospitals. It is easy to expand and the highly modular implementation offers antepartum and intrapartum alerting 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 Departments
Basic and advanced fetal trace alerting for both antepartum and intrapartum applications.
• The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information during obstetrical period, and to document relevant information (surveillance) as needed by care providers.
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/K970456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970456
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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