# K081203: OB Tracevue Obstetrical Information Management System with Release F.00

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: May 28, 2008 after 30 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970456 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System, Hewlett-Packard GmbH (1997) Summary page 1.

## Most influential descendants
- K100420: Philips Obtracevue Model SW Rev. G.00 (2010), 4 descendants of its own
- K173941: IntelliSpace Perinatal Rev.K.00 (2018), 1 descendant of its own
- K143695: Central Monitoring System (2015), 1 descendant of its own
- K111083: Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 (2011), 1 descendant of its own
- K220732: Mural Perinatal Surveillance (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081203
Methodology: https://510kreport.com/methodology