# K103172: Civ-OB (Plus)

- Pathway: 510(k) (Traditional)
- Applicant: Civnet Communication, Ltd.
- Decided: Mar 11, 2011 after 134 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: 5 generations back to K833395 (1984). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051175: Civ-OB Obstrical Monitoring Software Application, Civent Communications, Ltd. (2006) Summary page 2.
- K082704: Birthtrack (a.K.a. CLM), Barnev, Ltd. (2009) Summary page 2.

## Most influential descendants
- K143695: Central Monitoring System (2015), 1 descendant of its own
- K171178: Central Monitoring System (2017), 0 descendants of its own
- K153580: Central Monitoring System (2016), 0 descendants of its own

## Indications for use
The CIVNET CIV-obTM (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting The CIVNET CIV-obTM (plus) is intended to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record. The CIVNET CIV-obTM (plus) has display fields for the following obstetric data: * Monitoring site details * Patient demographics * Provider notes * FHR * Uterine Activity (via tocodynamometry IP) * Head Descent * Cervix Dilation

Source page: https://510kreport.com/device/K103172
Methodology: https://510kreport.com/methodology