# K974248: Watchchild Obsterical Patient Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Air-Shields, Inc.
- Decided: Oct 7, 1998 after 329 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: 2 generations back to K833395 (1984). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893981: Watchchild, Monox, Inc. (1990) Summary page 1.
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System, Hewlett-Packard GmbH (1997) Summary page 1.
- K870692: Perinatal Computers 2015/2025/2040/2045/2080/2085, Peritronics Research and Development, Inc. (1987) Summary page 1.
- K960109: Quantitative Sentinel System, Quantitative Medicine, Inc. (1996) Summary page 1.
- K903992: Cygnet Central, Cygnet Co., Inc. (1990) Summary page 1.
- (no number) Ams Dastar: named in the summary without a submission number

## Most influential descendants
- K014094: Modification to the Watchchild Obstetrical Patient Data Management System (2002), 1 descendant of its own
- K032772: Modification to Watchchild Obstetrical Patient Data Management System (Also Referred to as) the Watchchild System (2003), 0 descendants of its own

## Indications for use
The WatchChild™ System is a complete Obstetrical Information Management System which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial Fetal Stress Tests through post delivery discharge. WatchChild organizes clinical data which would normally be provided on paper records or other clinical systems and devices. This system serves as a deciston support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.

Source page: https://510kreport.com/device/K974248
Methodology: https://510kreport.com/methodology