# K241009: PeriCALM Patterns 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Perigen, Inc.
- Decided: Jan 10, 2025 after 273 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 K970456 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040788: Calm Patterns, Version 01.00.00, Lms Medical Systems, Ltd. (2005) Summary page 5.

## Indications for use
PeriCALM Patterns is intended for use to provide additional secondary information as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥32 weeks gestation for annotation and summary of the fetal heart rate recording for baseline, accelerations and decelerations and the uterine pressure recording for contractions. WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on PeriCALM Patterns annotations or summaries and should include inspection of the fetal monitor tracing and consideration of all pertinent clinical information.

Source page: https://510kreport.com/device/K241009
Methodology: https://510kreport.com/methodology