510(k) · Cleared
ClearedFM-1000 Plus 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 Sep 21, 2011 as substantially equivalent to K073221 (Edan Instruments, Inc., 2007) after a 54-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Sep 21, 2011
- Review
- 54 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852608 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- 3 generations backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- 2 generations backK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- 1 generation backK073221 Cadence IIEdan Instruments, Inc. · 2007
- This deviceK112187 FM-1000 Plus Fetal MonitorAdvanced Instrumentations, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| −3 | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| −1 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| 0 (this device) | K112187 | FM-1000 Plus Fetal Monitor | Advanced Instrumentations, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K073221 | Cadence IISummary page 2…ANCED INSTRUMENTATIONS, INC Page 1of 2 FM-10OO Pius Fetal Monitor Predicate Device: Cadence 11Fetal Monitor K073221 Manufacturer: EDAN Instruments Device Description: FM-i1000 Plus Fetal Monitor The FM-i 000 Plus Fetal Monitor can provide dif… | 2007 |
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 5.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K073221.
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-10OO Plus Fetal Monitor is used to monitor fetal well being during the antepartumn period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112187: FM-1000 Plus 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/K112187
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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