510(k) · Cleared
ClearedFetal Maternal Monitor Model F9 Express and Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · HGM System, Monitoring, Perinatal
Cleared on Nov 10, 2010 as substantially equivalent to K082602 (Edan Instruments, Inc., 2008) and 1 other predicate after a 233-day review. Its family tree reaches back 5 generations to 1985. 5 later devices descend from it.
- Decided
- Nov 10, 2010
- Review
- 233 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K852608 (1985). 13 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- 4 generations backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- 3 generations backK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- 2 generations backK073221 Cadence IIEdan Instruments, Inc. · 2007
- 1 generation backK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- This deviceK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK150901 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express…Edan Instruments, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK241882 Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK131941 Fetal MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK112317 FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · cites it directly2descendants
- K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc. · 2018 · 2 generations on1descendant
- K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025 · 3 generations on0descendants
- K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014 · cites it directly0descendants
- K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| −4 | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| −3 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| −2 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| −1 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| 0 (this device) | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +1 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015 | 1 |
| +2 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal… | Edan Instruments, Inc. | 2018 | 2 |
| +3 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | — |
| +1 | K131941 | Fetal Monitors | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
| +1 | K112317 | FM-9000 Plus Fetal and Maternal Monitor | Advanced Instrumentations, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K082602 | Fetal & Maternal Monitor, Model F6, F9Summary page 1…21 CFR 884.2740 Perinatal monitoring system and accessories. 6. Product Code: HGM 7; Predicate Devices: * Edan Instruments F9/F6 Maternal/Fetal Monitor K082602 * GE Healthcare GE129 Maternal/Fetal Monitor K991739 8. Device Description The Fetal & Maternal Monitor provi… | 2008 |
| * | K991739 | Corometrics 120 Series Maternal/Fetal MonitorSummary page 1…6. Product Code: HGM 7; Predicate Devices: * Edan Instruments F9/F6 Maternal/Fetal Monitor K082602 * GE Healthcare GE129 Maternal/Fetal Monitor K991739 8. Device Description The Fetal & Maternal Monitor provides the following primary features that can be available… | 1999 |
What descends from it? (5)
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 25 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K150901 (Edan Instruments, Inc., 2015) has gone furthest, with 2 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. 2010, this device’s year, is highlighted.
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?
F6 Express and F9 Express fetal & maternal monitor is intended for monitoring
physiological parameters of pregnant women during ante-partum examination, labor
and delivery. It is intended to be used only by trained and qualified personnel in ante-
partum examination rooms, labor and delivery rooms.
F6 Express and F9 Express fetal & maternal monitor is intended for providing Non-
Stress testing or fetal monitoring for pregnant women from the 28th week of gestation.
In addition, it provides a solution for maternal vital signs monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100797: Fetal Maternal Monitor Model F9 Express and Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100797
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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