510(k) · Cleared
Recalled · Class II · 2025MFM-CMS Central Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 21, 2013 as substantially equivalent to K062194 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) after a 469-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 21, 2013
- Review
- 469 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011093 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
- 1 generation backK062194 Hypervisor VI Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- This deviceK120727 MFM-CMS Central Monitoring SystemEdan Instruments, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK172966 CMS-2000 Central Monitoring SystemAdvanced Instumentations, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK170514 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154 | Agilent Technologies, Inc. | 2001 | 4 |
| −1 | K062194 | Hypervisor VI Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| 0 (this device) | K120727 | MFM-CMS Central Monitoring System | Edan Instruments, Inc. | 2013 | — |
| +1 | K172966 | CMS-2000 Central Monitoring System | Advanced Instumentations, Inc. | 2017 | — |
| +1 | K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K062194 | Hypervisor VI Central Monitoring SystemSummary page 1…tor, physiological, patient(with arrhythmia information;: detection or alarms) ' Class 11 - Product code: MHX Predicate Devices: HYPERVISOR VI Central Monitoring System (K062194) Device Description: The MFM-CMS Central Monitoring System is a software production which runs on PC platform with Microsoft Win… | 2007 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2025 | Class II | Z-1150-2026 | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172966 (Advanced Instumentations, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062194.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of…
Read the full statement (100 words)
MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software and hardware. The system is intended for use in a hospital/clinical environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120727: MFM-CMS 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/K120727
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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