# K173941: IntelliSpace Perinatal Rev.K.00

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Sep 10, 2018 after 258 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: 22 generations back to K941811 (1994). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100420: Philips Obtracevue Model SW Rev. G.00, Philips Medizin Systeme Boeblingen GmbH (2010) Summary page 4.

## Most influential descendants
- K220732: Mural Perinatal Surveillance (2022), 0 descendants of its own

## Indications for use
The Philips IntelliSpace Perinatal Obstetrical Information Management System is indicated for obstetric patients during and after pregnancy, who require monitoring in a healthcare setting. The Philips IntelliSpace Perinatal system 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 Remote Desktop Session (RDS). * An interface to launch the Philips IntelliVue XDS Remote Display for remote viewing and operating of compatible patient monitors.

Source page: https://510kreport.com/device/K173941
Methodology: https://510kreport.com/methodology