510(k) · Cleared
ClearedFM-9000 Plus Fetal and Maternal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Instrumentations, Inc. · HGM System, Monitoring, Perinatal
Cleared on Dec 21, 2011 as substantially equivalent to K100797 (Edan Instruments, Inc., 2010) after a 132-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Dec 21, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K852608 (1985). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- 5 generations backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- 4 generations backK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- 3 generations backK073221 Cadence IIEdan Instruments, Inc. · 2007
- 2 generations backK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- 1 generation backK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- This deviceK112317 FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| −5 | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| −4 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| −3 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| −2 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| −1 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K100797 | Fetal Maternal Monitor Model F9 Express and ExpressSummary page 2…INC Page I of 3 FM-9000 Plus Fetal and Maternal Monitor Predicate Device: F9 Express Fetal and Maternal Monitor K100797 Manufacturer: EDAN Instruments Device Description: FM-9000 Plus Fetal and Maternal Monitor The Fetal & Maternal Monitor provides… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K100797.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and 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/K112317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112317: FM-9000 Plus Fetal and 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/K112317
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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