510(k) · Cleared
ClearedMulti-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Comen Medical Instruments Co.,Ltd · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 17, 2025 as substantially equivalent to K213799 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2022) after a 271-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Dec 17, 2025
- Review
- 271 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K182075 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backK182075 BeneVision N Series Patient Monitors (Including BeneVision N12…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- 3 generations backK192972 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
- 2 generations backK202405 BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021
- 1 generation backK213799 N Series Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · Recalled
- This deviceK250854 Multi-parameter Patient Monitor (N10); Multi-parameter Patient…Shenzhen Comen Medical Instruments Co.,Ltd · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K182075 | BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| −3 | K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | — |
| −2 | K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | — |
| −1 | K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 2 |
| 0 (this device) | K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12)… | Shenzhen Comen Medical Instruments Co.,Ltd | 2025 | — |
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 |
|---|---|---|---|
| * | K213799 | N Series Patient MonitorsSummary page 7…Page 2 of 22 510(k) Premarket Notification 510(k) Summary K250854 3. Predicate device K213799 - BeneVision N series Patient Monitors (including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22)… | 2022 |
| † | K211619 | Multi-Parameter Patient Monitor | 2022 |
| † | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | 2020 |
| † | K123043 | Irma C02 Model 200101; Irma AX 200601 | 2012 |
| † | K171121 | Masimo Root Monitoring System and Accessories | 2017 |
| † | K042601 | Capnostat 5 | 2004 |
| † | K103604 | Isa CO2, Isa AX+, Isa or+ | 2011 |
| † | K040183 | BISX | 2004 |
| † | K102084 | Stimpod NMS450 Nerve Stimulator | 2010 |
| † | K231160 | Cardio Q50, Cardio Q70 | 2023 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K213799.
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. 2025, 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?
The N10, N12, N15, N1OMPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen…
Read the full statement (317 words)
The N10, N12, N15, N1OMPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (C02). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (02) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:
- Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
-NIBP measurement continual mode is not applicable to neonates.
- When using COMEN SpO2, the monitor is intended to be used on adult patient only.
- PAWP is intended for adult and pediatric patients only.
- C.O. measurement is intended for adult patients only.
- BIS monitoring is intended for adult patients only.
- RM is intended for adult and pediatric patients only.
- NMT monitoring is intended for adult and pediatric patients only.
The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.
The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.
The monitors are not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250854: Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250854
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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