# K980719: CALM

- Pathway: 510(k) (Traditional)
- Applicant: Lms Medical Systems, Ltd.
- Decided: Jul 31, 1998 after 157 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: 3 generations back to K833395 (1984). 5 ancestors in all.
2 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)
- K965008: Birthnet II Perinatal Patient Data Management System, Spacelabs Medical, Inc. (1997) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

Source page: https://510kreport.com/device/K980719
Methodology: https://510kreport.com/methodology