510(k) · Cleared
ClearedPassport Series Patient Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Biomedical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Aug 1, 2014 as substantially equivalent to K092449 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2010) and 1 other predicate after a 340-day review. Its family tree reaches back 2 generations to 2010. 1 later device descends from it.
- Decided
- Aug 1, 2014
- Review
- 340 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K092449 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK092449 Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · Recalled
- 1 generation backK123074 Imec, Ipm and Beneview T1 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- This deviceK132662 Passport Series Patient MonitorsShenzhen Mindray Biomedical Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K092449 | Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | 5 |
| −1 | K123074 | Imec, Ipm and Beneview T1 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| 0 (this device) | K132662 | Passport Series Patient Monitors | Shenzhen Mindray Biomedical Electronics Co., Ltd. | 2014 | — |
| +1 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 5…Class II 21 CFR 870.1435 Computer, Diagnostic, Pre-Programmed, Single-Function (DXG) Class II Legally Marketed Predicate Devices: K092449 BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 andBeneView T5), Shenzhen Mindray B… | 2010 |
| * | K123074 | Imec, Ipm and Beneview T1 Patient MonitorsSummary page 5…K092449 BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 andBeneView T5), Shenzhen Mindray Bio-medical Electronics Co., LTD K123074 IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS, Shenzhen Mindray Bio-medical Electronics Co., LTD Device Description… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | 2016 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K153448 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K092449.
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. 2014, 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 Passport Series Patient Monitors, including Passport 8 and Passport 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 (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood…
Read the full statement (190 words)
The Passport Series Patient Monitors, including Passport 8 and Passport 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 (Temp), 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:
y C.O. monitoring is restricted to adult patients only;
y PAWP monitoring is not intended for neonatal patients;
y 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.
y 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitors 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/K132662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132662: Passport Series Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132662
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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