510(k) · Cleared
ClearedCorometrics 115 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 Nov 29, 1984 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 29, 1984
- Review
- 93 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK843385 Corometrics 115 Fetal MonitorGe Medical Systems Information Technologies · 1984
- Descendant · cites it directly · 5 of its ownK013477 Toco Lite, Model TD-01Ventrex, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- Descendant · cites it directly · 2 of its ownK992811 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK140163 Koala TocoClinical Innovations, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK131889 Eum 100PROPromedic, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K013477Toco Lite, Model TD-01Ventrex, Inc. · 2002 · cites it directly5descendants
- K090145Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011 · 2 generations on2descendants
- K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000 · cites it directly2descendants
- K140163Koala TocoClinical Innovations, LLC · 2014 · 2 generations on0descendants
- K131889Eum 100PROPromedic, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K843385 | Corometrics 115 Fetal Monitor | Ge Medical Systems Information Technologies | 1984 | — |
| +1 | K013477 | Toco Lite, Model TD-01 | Ventrex, Inc. | 2002 | — |
| +2 | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| +1 | K992811 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | Epic Medical Equipment Services, Inc. | 2000 | — |
| +2 | K140163 | Koala Toco | Clinical Innovations, LLC | 2014 | — |
| +3 | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 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?
- Of its descendants, K013477 (Ventrex, Inc., 2002) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K843385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K843385: Corometrics 115 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/K843385
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026