# K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard GmbH
- Decided: Oct 3, 1997 after 239 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
No predicates in its family tree.
19 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HP Obstetrical Information Management System 80235B: named in the summary without a submission number
- (no number) HP Obstetrical Information Management System M1370A: named in the summary without a submission number

## Most influential descendants
- K052795: Philips Avalon Fetal Monitor, Models FM20 and FM30 (2005), 9 descendants of its own
- K062137: Modification to Philips Avalon Fetal Monitors FM20 and FM30 (2006), 8 descendants of its own
- K081203: OB Tracevue Obstetrical Information Management System with Release F.00 (2008), 7 descendants of its own
- K071800: Philips Avalon Fetal Monitors FM20 and FM30 (2007), 7 descendants of its own
- K100420: Philips Obtracevue Model SW Rev. G.00 (2010), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K970456
Methodology: https://510kreport.com/methodology