# K955559: Corometrics Fetal Movement Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Mar 5, 1996 after 90 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 K900480 (1990). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 1.

## Most influential descendants
- K991739: Corometrics 120 Series Maternal/Fetal Monitor (1999), 10 descendants of its own
- K082602: Fetal & Maternal Monitor, Model F6, F9 (2008), 6 descendants of its own
- K100797: Fetal Maternal Monitor Model F9 Express and Express (2010), 5 descendants of its own
- K150901: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (2015), 2 descendants of its own
- K032252: Model 120 Series Maternal/Fetal Monitor (2003), 2 descendants of its own

## Indications for use
The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines “gross fetal body movement” as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements.” Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.

Source page: https://510kreport.com/device/K955559
Methodology: https://510kreport.com/methodology