510(k) · Cleared
ClearedCorometrics 120 Series Maternal/Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · HGM System, Monitoring, Perinatal
Cleared on Aug 19, 1999 as substantially equivalent to K964770 (Ge Medical Systems Information Technologies, 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990. 10 later devices descend from it.
- Decided
- Aug 19, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K900480 (1990). 6 ancestors in all, the oldest K852608 (1985). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
- 1 generation backK955559 Corometrics Fetal Movement Detection KitGe Medical Systems Information Technologies · 1996
- This deviceK991739 Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- Descendant · cites it directly · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK150901 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK032252 Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2003
- Descendant · 3 generations on · 1 of its ownK173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express…Edan Instruments, Inc. · 2018 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · cites it directly6descendants
- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · cites it directly5descendants
- K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · 2 generations on2descendants
- K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2003 · cites it directly2descendants
- K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900480 | M1350A Fetal Monitor (Intrapartum) | Hewlett-Packard Co. | 1990 | — |
| −1 | K955559 | Corometrics Fetal Movement Detection Kit | Ge Medical Systems Information Technologies | 1996 | — |
| 0 (this device) | K991739 | Corometrics 120 Series Maternal/Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| +1 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +1 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +2 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015 | 1 |
| +1 | K032252 | Model 120 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 2003 | — |
| +3 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal… | Edan Instruments, Inc. | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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.
Planning a device in HGM? 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? (3)
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 |
|---|---|---|---|
| * | K964770 | Corometrics 120 Series Maternal/Fetal MonitorSummary page 1…)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems). Predicate System Manufacturer k Number 120 Series Maternal/ GE Marquette Medical Systems, k964770, Fetal Monitor Inc SE: 2/21/97 Fetal Movement 61 Barnes Park Road North k955559, Detection Wallingford, CT 06492 SE: 3/5/96 Spect… | 1997 |
| * | K955559 | Corometrics Fetal Movement Detection KitSummary page 1…Predicate System Manufacturer k Number 120 Series Maternal/ GE Marquette Medical Systems, k964770, Fetal Monitor Inc SE: 2/21/97 Fetal Movement 61 Barnes Park Road North k955559, Detection Wallingford, CT 06492 SE: 3/5/96 Spectra 400 Extended k852608, Surveillance and Alerts SE: 9/29/85 System [807.92(a)4… | 1996 |
| * | K852608 | Spectra 400 Extended Surveillance & Alert SystemSummary page 1…Medical Systems, k964770, Fetal Monitor Inc SE: 2/21/97 Fetal Movement 61 Barnes Park Road North k955559, Detection Wallingford, CT 06492 SE: 3/5/96 Spectra 400 Extended k852608, Surveillance and Alerts SE: 9/29/85 System [807.92(a)4 & 807.92(a)5] Device Description & Intended Use The 120 Series is inten… | 1985 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K082602 (Edan Instruments, Inc., 2008) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K964770.
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?
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…
Read the full statement (209 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991739 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991739: Corometrics 120 Series Maternal/Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991739
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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