# K040788: Calm Patterns, Version 01.00.00

- Pathway: 510(k) (Traditional)
- Applicant: Lms Medical Systems, Ltd.
- Decided: Feb 8, 2005 after 316 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: 1 generation back to K970456 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System, Hewlett-Packard GmbH (1997) Summary page 1.

## Most influential descendants
- K241009: PeriCALM Patterns 3.0 (2025), 0 descendants of its own

## Indications for use
CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.

Source page: https://510kreport.com/device/K040788
Methodology: https://510kreport.com/methodology