510(k) · Cleared
ClearedCMS-1000FM Central Monitoring System
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 K100358 (Edan Instruments, Inc., 2011) after a 56-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Sep 21, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100358 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK100358 Central Monitoring SystemEdan Instruments, Inc. · 2011
- This deviceK112159 CMS-1000FM Central Monitoring SystemAdvanced Instrumentations, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100358 | Central Monitoring System | Edan Instruments, Inc. | 2011 | — |
| 0 (this device) | K112159 | CMS-1000FM Central Monitoring System | Advanced Instrumentations, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K100358 | Central Monitoring SystemSummary page 2…Page 1 of 3 CMS- I OOOFM Central Monitoring System Predicate Device: Central Monitoring System (model .MFM-CNS) K100358 Manufacturer: EDAN Instruments Device Description: CMS-1000FM Central Monitoring System is a software product that runs on a PC… | 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?
- Its one ancestor has no recall.
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 CMS-1000FM Central Monitoring System (hereinafter called "OMS-IOOOFM") is a clinical data managing software application and is indicated for antepartumn and intrapartumn monitoring of pregnant women in a healthcare setting.
The CMS-1000FM is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.
The CMS-1000FM has display fields for the following obstetric data:
patient demographics
provider notes
FHR
uterine activity (via tocodynamometry or IUP)
maternal heart rate
SpO 2
NIBP
respiratory rate
temperature
pulse rate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112159: CMS-1000FM Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112159
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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