# K080226: Navicare -Watchchild Obstetrical Data Management System (Navicare -Watchchild), Model P2912

- Pathway: 510(k) (Special)
- Applicant: Hill-Rom Manufacturing, Inc.
- Decided: Apr 9, 2008 after 71 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NaviCare® WatchChildTM is indicated for use in a hospital/clinical environment. NaviCare® WatchChildTM is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChildTM organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

Source page: https://510kreport.com/device/K080226
Methodology: https://510kreport.com/methodology