510(k) · Cleared
ClearedBeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 10, 2018 after a 131-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Dec 10, 2018
- Review
- 131 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK182075 BeneVision N Series Patient Monitors (Including BeneVision N12…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 7 of its ownK192972 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 5 of its ownK191769 ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK202405 BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK213799 N Series Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK200015 ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K192972Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · cites it directly7descendants
- K191769ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · cites it directly5descendants
- K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021 · 2 generations on4descendants
- K213799N Series Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · 3 generations on2descendants
- K200015ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182075 | BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +1 | K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | — |
| +1 | K191769 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
| +2 | K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | — |
| +3 | K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 2 |
| +2 | K200015 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 153 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192972 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2020) has gone furthest, with 7 descendants of its own.
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. 2018, 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 | — |
https://510kreport.com/device/K182075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182075: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182075
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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