# K021135: Model 2120IS Series Maternal/Fetal Monitor

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: May 9, 2002 after 30 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K833395 (1984). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012718: Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System., Ge Medical Systems Information Technologies (2001) Summary page 1.
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 1.

## Recalls of this device
- May 21, 2003 · Not classified · Z-1291-03: The 2120 Main Board on device lacks required external safety 'watchdog' circuit.

## Indications for use
Fetal Surveillance A Corometrics 2120is Maternal/Fetal Monitoring System 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) are available. Maternal Monitoring A Corometrics 2120is Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized as follows: 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 the 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 (MSpQO2). Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, an MECG waveform “snapshot” may be displayed and printed. NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data. Bed-to-bed surveillance is available when 2120is Series Monitors are networked together.

Source page: https://510kreport.com/device/K021135
Methodology: https://510kreport.com/methodology