510(k) · Cleared
ClearedModel 118 Fetal/Maternal 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 Aug 15, 1994 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Aug 15, 1994
- Review
- 304 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK934959 Model 118 Fetal/Maternal MonitorGe Medical Systems Information Technologies · 1994
- Descendant · cites it directly · 16 of its ownK964770 Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997
- Descendant · 2 generations on · 10 of its ownK991739 Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- Descendant · 3 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK994008 Biosys Fetal Monitor, Model Ifm-500Biosys Co., Ltd. · 2000
- Descendant · 3 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K964770Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997 · cites it directly16descendants
- K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999 · 2 generations on10descendants
- K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 3 generations on6descendants
- K994008Biosys Fetal Monitor, Model Ifm-500Biosys Co., Ltd. · 2000 · cites it directly6descendants
- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934959 | Model 118 Fetal/Maternal Monitor | Ge Medical Systems Information Technologies | 1994 | — |
| +1 | K964770 | Corometrics 120 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 1997 | — |
| +2 | K991739 | Corometrics 120 Series Maternal/Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| +3 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +1 | K994008 | Biosys Fetal Monitor, Model Ifm-500 | Biosys Co., Ltd. | 2000 | — |
| +3 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 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? (25)
See all 254 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, K964770 (Ge Medical Systems Information Technologies, 1997) has gone furthest, with 16 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/K934959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934959: Model 118 Fetal/Maternal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934959
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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