# K100420: Philips Obtracevue Model SW Rev. G.00

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Jul 26, 2010 after 160 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: 21 generations back to K941811 (1994). 128 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081203: OB Tracevue Obstetrical Information Management System with Release F.00, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 2.
- K071800: Philips Avalon Fetal Monitors FM20 and FM30, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 2.
- K031403: M3290A Intellivue Information Center Software Release E.1, Philips Medical Systems, Inc. (2003) Summary page 2.
- K050742: M3290A Intellivue Information Center Software Release G.00, Philips Medical Systems (2005) Summary page 2.

## Most influential descendants
- K173941: IntelliSpace Perinatal Rev.K.00 (2018), 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
- K140535: Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 (2014), 0 descendants of its own

## Indications for use
The Philips OH TraceVue Obstetrical Information Management System is indicated for obstetric patients during and after pregnancy, who require monitoring in a healthcare setting The Philips OH Tracevue provides * Basic and advanced fetal trace alarming for both antepartum and intrapartum patients * Central monitoring of maternal alarming. * Documentation capabilities and data storage. * Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility web access (intra/internet).

Source page: https://510kreport.com/device/K100420
Methodology: https://510kreport.com/methodology