# K080672: Birthtrack

- Pathway: 510(k) (Special)
- Applicant: Barnev, Ltd.
- Decided: Jul 8, 2008 after 120 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: 2 generations back to K771553 (1977). 8 ancestors in all.
5 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)
- DEN060006: Computerized Labor Monitoring System, Barnev, Ltd. (2007). Our reading of the summary gave K060028, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060006, Computerized Labor Monitoring System (Barnev, Ltd.), granted Jan 30, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K844608: Surgicraft Copeland Disposable, A.W. Showell (Surgicraft), Ltd. (1985) Summary page 1.
- K030691: Fetal Spiral Electrode, Model FSE07000, Clinical Innovations, Inc. (2003) Summary page 2.

## Most influential descendants
- K082704: Birthtrack (a.K.a. CLM) (2009), 4 descendants of its own
- 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/K080672
Methodology: https://510kreport.com/methodology