510(k) · Cleared
ClearedCentral Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Biolight Meditech Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 24, 2017 as substantially equivalent to K120727 (Edan Instruments, Inc., 2013) after a 92-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 24, 2017
- Review
- 92 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011093 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
- 2 generations backK062194 Hypervisor VI Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK120727 MFM-CMS Central Monitoring SystemEdan Instruments, Inc. · 2013 · Recalled
- This deviceK170514 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154 | Agilent Technologies, Inc. | 2001 | 4 |
| −2 | K062194 | Hypervisor VI Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −1 | K120727 | MFM-CMS Central Monitoring System | Edan Instruments, Inc. | 2013 | 1 |
| 0 (this device) | K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K120727 | MFM-CMS Central Monitoring SystemSummary page 5…es out alarm to remind doctors and nurses for attention. 5. Identification of Predicate Device and Reference Device Predicate Device 510(k) Number: K120727 Product Name: Central monitoring system Model Name: MFM-CMS Reference Device 510(k) Number: K153580 Pr… | 2013 |
| † | K153580 | Central Monitoring System | 2016 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K120727.
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. 2017, 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?
Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient’s vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP)…
Read the full statement (98 words)
Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient’s vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170514: 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/K170514
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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