# K012718: Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 13, 2001 after 90 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833395 (1984). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.
- K993008: Quantitative Sentinel System, Marquette Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K021135: Model 2120IS Series Maternal/Fetal Monitor (2002), 0 descendants of its own

## Recalls of this device
- Sep 19, 2019 · Class II · Z-0979-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Sep 19, 2019 · Class II · Z-0980-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to a
- Sep 19, 2019 · Class II · Z-0982-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Sep 19, 2019 · Class II · Z-0983-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Sep 19, 2019 · Class II · Z-0981-2020: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Sep 11, 2019 · Class II · Z-1163-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1168-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1161-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1160-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1164-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1167-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1162-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1166-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1159-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi
- Sep 11, 2019 · Class II · Z-1165-2020: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inabi

## Indications for use
Fetal Surveillance A Corometrics 120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout tabor 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 120is 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 {(MSp0O2). 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 120is Series Monitors are networked together

Source page: https://510kreport.com/device/K012718
Methodology: https://510kreport.com/methodology