# K991739: Corometrics 120 Series Maternal/Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Aug 19, 1999 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: 2 generations back to K900480 (1990). 6 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964770: Corometrics 120 Series Maternal/Fetal Monitor, Ge Medical Systems Information Technologies (1997) Summary page 1.
- K955559: Corometrics Fetal Movement Detection Kit, Ge Medical Systems Information Technologies (1996) Summary page 1.
- K852608: Spectra 400 Extended Surveillance & Alert System, Ge Medical Systems Information Technologies (1985) Summary page 1.

## Most influential descendants
- 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
- K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (2018), 1 descendant of its own

## Indications for use
Fetal Surveillance A Corometrics 120 Series Monitor is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms or Spectra alerts) are available. Maternal Monitoring A Corometrics 120 Series Monitor is intended for fnonitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized below. NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms. Blood Pressure. The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring. Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO,). Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, a MECG waveform “snapshot” may be displayed and printed. NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Source page: https://510kreport.com/device/K991739
Methodology: https://510kreport.com/methodology