510(k) · Cleared
ClearedImec, Ipm and Beneview T1 Patient Monitors
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 Jul 3, 2013 as substantially equivalent to K092449 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2010) after a 275-day review. Its family tree reaches back 1 generation to 2010. 7 later devices descend from it.
- Decided
- Jul 3, 2013
- Review
- 275 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092449 (2010). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK092449 Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · Recalled
- This deviceK123074 Imec, Ipm and Beneview T1 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK132662 Passport Series Patient MonitorsShenzhen Mindray Biomedical Electronics Co., Ltd. · 2014
- Descendant · 4 generations on · 0 of its ownK201746 Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · cites it directly3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 2 generations on2descendants
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 3 generations on1descendant
- K132662Passport Series Patient MonitorsShenzhen Mindray Biomedical Electronics Co., Ltd. · 2014 · cites it directly1descendant
- K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092449 | Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | 5 |
| 0 (this device) | K123074 | Imec, Ipm and Beneview T1 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| +1 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +2 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +3 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
| +1 | K132662 | Passport Series Patient Monitors | Shenzhen Mindray Biomedical Electronics Co., Ltd. | 2014 | — |
| +4 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K092449 | Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5Summary page 2…Class It 21 CFR 870.1435 Single-function, preprogrammed diagnostic computer. Class HI Legally Marketed Predicate Devices: K092449, BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 and BeneView T5). Shenzhen Mi… | 2010 |
What descends from it? (7)
3 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?
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?
The iMEC Series Patient Monitors, including iMEC8, iMEC10 and iMEC12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac…
Read the full statement (469 words)
The iMEC Series Patient Monitors, including iMEC8, iMEC10 and iMEC12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2).
All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:
- C.O. monitoring is restricted to adult patients only;
- PAWP monitoring is not intended for neonatal patients;
- The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
The iPM Series Patient Monitors, including iPM 8, iPM 10 and iPM 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).
All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:
- C.O. monitoring is restricted to adult patients only;
- PAWP monitoring is not intended for neonatal patients;
- The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
- 12-lead monitoring and AG monitoring are available for iPM 10 and iPM 12 Patient Monitors only.
The BeneView T1 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration, temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2).
All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:
- C.O. monitoring is restricted to adult patients only;
- PAWP monitoring is not intended for neonatal patients;
- The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for Adult and Pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123074: Imec, Ipm and Beneview T1 Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123074
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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