510(k) · Cleared
Recalled · 2003Model 2120IS 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 May 9, 2002 as substantially equivalent to K012718 (Ge Medical Systems Information Technologies, 2001) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1984. It has been recalled once.
- Decided
- May 9, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K833395 (1984). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 4 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 3 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 2 generations backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- 1 generation backK012718 Modification to Corometrics Model 120IS Maternal/Fetal Monitoring…Ge Medical Systems Information Technologies · 2001 · Recalled
- This deviceK021135 Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −4 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −3 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −2 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| −1 | K012718 | Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System. | Ge Medical Systems Information Technologies | 2001 | 15 |
| 0 (this device) | K021135 | Model 2120IS Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 2002 | — |
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 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K012718 | Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.Summary page 1…hnologies Phone: 203-949-8232 Fax: 414-918-8113 Corometrics Model 2120is Maternal/Fetal Monitor Maternal/Fetal Monitor 21 CFR 884.2740 System, Monitoring, Perinatal K012718 Corometrics Model 2120is Maternal/Fetal Monitor K990966 Masimo SET® 2000 Pulse Oximeter and LNOP® series of sensors and cables… | 2001 |
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 1…rics Model 2120is Maternal/Fetal Monitor Maternal/Fetal Monitor 21 CFR 884.2740 System, Monitoring, Perinatal K012718 Corometrics Model 2120is Maternal/Fetal Monitor K990966 Masimo SET® 2000 Pulse Oximeter and LNOP® series of sensors and cables The 2120is Maternal/Fetal Monitoring System consists of t… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2003 | Not classified | Z-1291-03 | Other | The 2120 Main Board on device lacks required external safety 'watchdog' circuit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 14 ancestors have a recall of any class.
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 2120is 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. Maternal Monitoring A Corometrics 2120is Maternal/Fetal…
Read the full statement (221 words)
Fetal Surveillance
A Corometrics 2120is 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.
Maternal Monitoring
A Corometrics 2120is 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 (MSpQO2).
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 2120is 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/K021135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021135: Model 2120IS 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/K021135
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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