# K965008: Birthnet II Perinatal Patient Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Dec 16, 1997 after 365 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K833395 (1984). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K960109: Quantitative Sentinel System, Quantitative Medicine, Inc. (1996) Summary page 1.
- K893981: Watchchild, Monox, Inc. (1990) Summary page 1.

## Most influential descendants
- K980719: CALM (1998), 2 descendants of its own
- K102263: Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 (2011), 0 descendants of its own
- K052715: Calm Curve, Version 01.00 (2005), 0 descendants of its own

## Recalls of this device
- Oct 13, 2005 · Not classified · Z-0115-06: Potential for incorrect weight to be displayed.

## Indications for use
The BirthNet™ Il Perinatal Patient Data Management System is designed for use in the following functions: a) Collect fetal monitor data for the purpose of central surveillance, local surveillance, review, annotation, and for archiving data for long storage. b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM). c) Collect physiological, maternal and fetal data directly from physiological monitors and append such data to the proper patient database table. d) Feed back selected data items to the AMS fetal monitor for the purpose of printing such data on the fetal monitor strip in real time. e) Enable manual patient data entry into the system for the purpose of charting. f) Assemble and display selected data in a summary format of r more efficient review capability by the care giver. g) Validate data entry when applicable to ensure data integrity. h) Print pre-formatted reports on individual patients i) Reproduce fetal monitor records from storage to a printer or an AMS UR10 (stripped down fetal monitor) recorder. j) Transmit selected items from the database via fax. k) Enable authorized (password) care giver to access the system remotely. l) Generate an audit trail for all transactions. m) Generate statistics reports for quality assurance. n) Facilitate the generation of a birth certificate by providing pertinent patient data acquired by the system.

Source page: https://510kreport.com/device/K965008
Methodology: https://510kreport.com/methodology