510(k) · Cleared
Recalled · Class II · 2014V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mindray DS USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Dec 20, 2013 as substantially equivalent to K102004 (Mindray DS USA, Inc., 2010) after a 172-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2013
- Review
- 172 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K933143 (1994). 35 ancestors in all, the oldest K842616 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 7 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 6 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 5 generations backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- 4 generations backK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- 3 generations backK031849 Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp. · 2003 · Recalled
- 2 generations backK062098 Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp. · 2007
- 1 generation backK102004 Endeavour Monitoring SystemMindray DS USA, Inc. · 2010 · Recalled
- This deviceK132026 V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 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 2 of 2 · See all- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −7 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −6 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −5 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| −4 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| −3 | K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | Datascope Corp. | 2003 | 1 |
| −2 | K062098 | Spectrum Monitor, Model 0998-00-1000-Xxxxx | Datascope Corp. | 2007 | — |
| −1 | K102004 | Endeavour Monitoring System | Mindray DS USA, Inc. | 2010 | 3 |
| 0 (this device) | K132026 | V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 | Mindray DS USA, Inc. | 2013 | — |
| +1 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102004 | Endeavour Monitoring SystemSummary page 1…d Diagnostic Computer §822.1620- GWM- Intracranial Pressure Monitoring Device Predicate Device: Endeavour Monitoring System/K 102004 Mindray DS LISA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary Section 5- 510(k)… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150352 | V Series Monitoring System (including V12 and V21 Monitors) | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2014 | Class II | Z-0107-2015 | Software design | Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 35 ancestors have a recall of any class.
- Of its descendants, K150352 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) has gone furthest, with 1 descendant 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. 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 V Series Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters: * ECG waveform derived from 3, 5.6 and 12 Lead measurements * Heart Rate * Pulse Oximetry (SpO:) * ST Segment Analysis * Arrhythmia Detection * Non Invasive Blood Pressure (NIBP) * Invasive Blood Pressure (IBP)…
Read the full statement (207 words)
The V Series Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
* ECG waveform derived from 3, 5.6 and 12 Lead measurements
* Heart Rate
* Pulse Oximetry (SpO:)
* ST Segment Analysis
* Arrhythmia Detection
* Non Invasive Blood Pressure (NIBP)
* Invasive Blood Pressure (IBP)
* Cardiac Output (CO)
* Respiratory Gasses
* Respiration Rate
* Temperature
The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
* Arrhythmia detection and ST Segment Analysis. for which the target populations are adult and pediatric only.
* IV Drug Calculations for which the target population is adult only. and
* Cardiac Output for which the target population is adult and pediatric only.
The V' Series utilizes the following modules for measuring the indicated parameters:
* VPS Module (multi parameter including 3/5/6/12 lead ECG. respiration, pulse oxymetry temperature, non invasive blood pressure and invasive blood pressure)
* Temperature Module
* Invasive Blood Pressure Module
* Cardiac Output Module
* Respiratory Gas Module
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132026: V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132026
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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