# DEN060006: Computerized Labor Monitoring System

- Pathway: De Novo (Post-NSE)
- Applicant: Barnev, Ltd.
- Decided: Jan 30, 2007 after 104 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K080672: Birthtrack (2008), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/DEN060006
Methodology: https://510kreport.com/methodology