510(k) · Cleared
Recalled · Class II · 2019Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.
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 Nov 13, 2001 as substantially equivalent to K964770 (Ge Medical Systems Information Technologies, 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it. It has been recalled 15 times.
- Decided
- Nov 13, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 15
- Predicates
- 2
Its longest line of descent runs back 4 generations to K833395 (1984). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 3 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 2 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 1 generation backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- This deviceK012718 Modification to Corometrics Model 120IS Maternal/Fetal Monitoring…Ge Medical Systems Information Technologies · 2001
- Descendant · cites it directly · 0 of its ownK021135 Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K021135Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −3 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −2 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −1 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| 0 (this device) | K012718 | Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System. | Ge Medical Systems Information Technologies | 2001 | — |
| +1 | K021135 | Model 2120IS Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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…uivalent Devices (Predicate Systems). 120 Series Maternal/ Fetal Monitor GE Medical Systems Information Technologies 61 Barnes Park Road North Wallingford, CT 06492 k964770, SE: 2/21/97 QS System GE Medical Systems Information Technologies 445 Defense Highway Annapolis, MD 21401 k993008 SE: 12/6/9… | 1997 |
| * | K993008 | Quantitative Sentinel SystemSummary page 1…61 Barnes Park Road North Wallingford, CT 06492 k964770, SE: 2/21/97 QS System GE Medical Systems Information Technologies 445 Defense Highway Annapolis, MD 21401 k993008 SE: 12/6/99 [807.92(a)4 & 807.92(a)5] Device Description & Intended Use The Corometrics Model 120is Maternal/Fetal Monitor is i… | 1999 |
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 |
|---|---|---|---|
| K021135 | Model 2120IS Series Maternal/Fetal Monitor | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2019 | Class II | Z-0979-2020 | No Marketing Application | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| Sep 19, 2019 | Class II | Z-0980-2020 | No Marketing Application | 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 accurately detect maternal peripheral… |
| Sep 19, 2019 | Class II | Z-0982-2020 | No Marketing Application | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| Sep 19, 2019 | Class II | Z-0983-2020 | No Marketing Application | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| Sep 19, 2019 | Class II | Z-0981-2020 | No Marketing Application | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| Sep 11, 2019 | Class II | Z-1163-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1168-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1161-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1160-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1164-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1167-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1162-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1166-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1159-2020 | Device Design | 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: inability to accurately detect and measure… |
| Sep 11, 2019 | Class II | Z-1165-2020 | Device Design | 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: inability to accurately detect and measure… |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K021135 (Ge Medical Systems Information Technologies, 2002) has gone furthest, with 0 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 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…
Read the full statement (221 words)
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
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/K012718 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012718: Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026