510(k) · Cleared
ClearedFM-3000 Fetal 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 Nov 19, 2014 as substantially equivalent to K102140 (Edan Instruments, Inc., 2011) after a 195-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Nov 19, 2014
- Review
- 195 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K852608 (1985). 8 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 backK082369 Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008
- 1 generation backK102140 Fetal Monitors, Models F2 and F3Edan Instruments, Inc. · 2011 · Recalled
- This deviceK141194 FM-3000 Fetal MonitorAdvanced Instrumentations, Inc. · 2014
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 | K082369 | Cadence, Cadence Dual, Cadence II Fetal Monitor | Edan Instruments, Inc. | 2008 | — |
| −1 | K102140 | Fetal Monitors, Models F2 and F3 | Edan Instruments, Inc. | 2011 | 1 |
| 0 (this device) | K141194 | FM-3000 Fetal Monitor | Advanced Instrumentations, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K102140 | Fetal Monitors, Models F2 and F3Summary page 6…K141194 Page 2 of 4 Predicate Device: F3 Fetal Monitor K102140 Manufacturer: EDAN Instruments Device Description: FM-3000 Fetal Monitor With non-invasive ultrasound Doppler, external pressu… | 2011 |
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 29 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K102140.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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-3000 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
It provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141194: FM-3000 Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141194
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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