510(k) · Cleared
ClearedModel 250 Series Maternal/Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · HGM System, Monitoring, Perinatal
Cleared on Jun 21, 2005 as substantially equivalent to K032252 (Ge Medical Systems Information Technologies, 2003) and 6 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1997. 2 of the 37 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 21, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K962603 (1997). 35 ancestors in all, the oldest K852608 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK021089 Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc. · 2002
- This deviceK050583 Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 0 of its ownK072976 Model 250CX Series Maternal/Fetal MonitorGE Healthcare · 2007
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K021089 | Oximax Max-Fast Adhesive Forehead Sensor | Nellcor Puritan Bennett, Inc. | 2002 | — |
| 0 (this device) | K050583 | Model 250 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K072976 | Model 250CX Series Maternal/Fetal Monitor | GE Healthcare | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 1 |
| 2003 | 5 | 0 |
| 2004 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032252 | Model 120 Series Maternal/Fetal MonitorSummary page 1…Series Maternal/Fetal Monitor Common/Usual Name: Maternal/Fetal Monitor Classification Names: 21 CFR 884.2740 System, Monitoring, Perinatal Predicate Devices: K032252 Corometrics Model 120is Maternal/Fetal Monitor K022834 DINAMAP PRO 1000 with SuperSTAT… | 2003 |
| * | K022834 | Dinamap Pro 1000 Monitor with Superstat, Model 1000Summary page 1…sification Names: 21 CFR 884.2740 System, Monitoring, Perinatal Predicate Devices: K032252 Corometrics Model 120is Maternal/Fetal Monitor K022834 DINAMAP PRO 1000 with SuperSTAT K040831 Datex Ohmeda SpO2… | 2003 |
| * | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Summary page 1…Predicate Devices: K032252 Corometrics Model 120is Maternal/Fetal Monitor K022834 DINAMAP PRO 1000 with SuperSTAT K040831 Datex Ohmeda SpO2 2 K012891/K021089/K0309… | 2004 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 1…MAP PRO 1000 with SuperSTAT K040831 Datex Ohmeda SpO2 2 K012891/K021089/K030930 Nellcor SpO K033296 Masimo SpO 2 Device Description: The Corometrics 250 Series Mat… | 2002 |
| * | K021089 | Oximax Max-Fast Adhesive Forehead SensorSummary page 1…1000 with SuperSTAT K040831 Datex Ohmeda SpO2 2 K012891/K021089/K030930 Nellcor SpO K033296 Masimo SpO 2 Device Description: The Corometrics 250 Series Maternal/Fe… | 2002 |
| * | K030930 | Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NSummary page 1…h SuperSTAT K040831 Datex Ohmeda SpO2 2 K012891/K021089/K030930 Nellcor SpO K033296 Masimo SpO 2 Device Description: The Corometrics 250 Series Maternal/Fetal Moni… | 2003 |
| * | K033298 | SPO2.Com Oximetry Sensors, Multiple Models 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”. | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072976 | Model 250CX Series Maternal/Fetal Monitor | 2007 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 10 of the 35 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K072976 (GE Healthcare, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (208 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050583: Model 250 Series Maternal/Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050583
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026