# K082704: Birthtrack (a.K.a. CLM)

- Pathway: 510(k) (Traditional)
- Applicant: Barnev, Ltd.
- Decided: Jan 9, 2009 after 115 days
- Product code: NPB (System, Monitoring, For Progress Of Labor)
- Device class: 2
- Regulation: 21 CFR 884.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K771553 (1977). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080672: Birthtrack, Barnev, Ltd. (2008) Summary page 1.

## 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 BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers: attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.

Source page: https://510kreport.com/device/K082704
Methodology: https://510kreport.com/methodology