# K050583: Model 250 Series Maternal/Fetal Monitor

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jun 21, 2005 after 106 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: 6 generations back to K962603 (1997). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032252: Model 120 Series Maternal/Fetal Monitor, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K022834: Dinamap Pro 1000 Monitor with Superstat, Model 1000, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K021089: Oximax Max-Fast Adhesive Forehead Sensor, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K030930: Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N, Nellcor Puritan Bennett, Inc. (2003) Summary page 1.
- K033298: SPO2.Com Oximetry Sensors, Multiple Models, Masimo Corp. (2003). Our reading of the summary gave K033296, FDA’s number for Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set… (Masimo Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Masimo SpO2”.

## Most influential descendants
- K072976: Model 250CX Series Maternal/Fetal Monitor (2007), 0 descendants of its own

## Indications for use
A Corometrics 250 Series 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. A Corometrics 250 Series 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 (MSpO2). 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.

Source page: https://510kreport.com/device/K050583
Methodology: https://510kreport.com/methodology