# K051175: Civ-OB Obstrical Monitoring Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Civent Communications, Ltd.
- Decided: Feb 17, 2006 after 287 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: 4 generations back to K833395 (1984). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993008: Quantitative Sentinel System, Marquette Medical Systems, Inc. (1999) Summary page 2.
- K931133: Clinical Infor Syst (Cis) W/Fetal Monit Remote Disp, Clinicomp, Inc. (1995) Summary page 2.

## Most influential descendants
- K103172: Civ-OB (Plus) (2011), 3 descendants of its own
- 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-ob software application is intended for automatic fetal monitor patient data management. The application does this by: a) Displaying on-line fetal heart rate and TOCO data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal monitor paper printout. b) Providing the means to control and display multiple beds simultaneously. c) Providing automatic Archiving of the data. d) Provide the ability to interface with different fetal monitors operating with the same interface protocol. e) Easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record. f) Provide visual notification of when acquired fetal monitor heart rate exceed the user defined limits for high and low fetal heart rate and poor signal quality. g) Providing the ability to record, with patient record, fluid input and output information that is defined by the user. h) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). i) Providing the ability to print (locally or remote) patient records. j) Providing the ability to review fetal monitor data remotely over the TCP/IP

Source page: https://510kreport.com/device/K051175
Methodology: https://510kreport.com/methodology