# K964770: Corometrics 120 Series Maternal/Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Feb 21, 1997 after 86 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 K911310 (1991). 2 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934959: Model 118 Fetal/Maternal Monitor, Ge Medical Systems Information Technologies (1994) Summary page 1.
- K911310: Corometrics 5566AAX Noninvasive Blood Pressure Mod, Ge Medical Systems Information Technologies (1991) 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 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp07. The device is intended for use in a hospital/clinical environment.

Source page: https://510kreport.com/device/K964770
Methodology: https://510kreport.com/methodology