# K052715: Calm Curve, Version 01.00

- Pathway: 510(k) (Special)
- Applicant: Lms Medical Systems (Canada), Ltd.
- Decided: Dec 22, 2005 after 84 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: 4 generations back to K833395 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980719: CALM, Lms Medical Systems, Ltd. (1998) Summary page 1.

## Indications for use
CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks.

Source page: https://510kreport.com/device/K052715
Methodology: https://510kreport.com/methodology