510(k) · Cleared

Cleared

Hypervisor VI Central Monitoring System

K062194510(k) TraditionalCleared Apr 11, 2007254-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Apr 11, 2007 as substantially equivalent to K011093 (Agilent Technologies, Inc., 2001) after a 254-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it.

Decided: Apr 11, 2007
Review: 254 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011093 (2001). 25 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
This deviceK062194 Hypervisor VI Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Descendant · cites it directly · 20 of its ownK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
Descendant · 2 generations on · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
Descendant · 3 generations on · 14 of its ownK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Descendant · 4 generations on · 12 of its ownK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · Recalled
Descendant · 5 generations on · 11 of its ownK183238 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2008high 4 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 25 · See all

K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly20descendants
K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 2 generations on17descendants
K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on14descendants
K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 4 generations on12descendants
K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011093	Agilent Information Center Software for M3150,M3151,M3153 and M3154	Agilent Technologies, Inc.	2001	4
0 (this device)	K062194	Hypervisor VI Central Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2007	—
+1	K080192	Hypervisor VI Central Monitoring System (Including TMS)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	2
+2	K132036	Hypervisor Central Monitoring System (Including Telemetry Monitoring System…	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	2014	—
+3	K150632	Hypervisor IX Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2015	2
+4	K162607	BeneVision Central Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2017	1
+5	K183238	BeneVision Central Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2013	1	0
2014	2	0
2015	3	0
2016	1	0
2017	4	0
2019	1	0
2020	1	0
2022	1	0
2023	2	0
2024	2	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K062194, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K011093	Agilent Information Center Software for M3150,M3151,M3153 and M3154 Summary page 2 …gen Gas Analyzer Class II ko(2(ff Legally Marketed Predicate Device: K011093 Agilent Technologies Information Center (AIC) Software Description: Central Monitoring System is a kind of medical in…	Agilent Technologies, Inc.	2001	4

Also cleared against K011093: 6 other devices →

What descends from it? (25)

See all 25

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080192	Hypervisor VI Central Monitoring System (Including TMS)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	20
K120727	MFM-CMS Central Monitoring System	Edan Instruments, Inc.	2013	2
K092153	Skyline 55, Model Ver 1	Larsen & Toubro Limited	2009	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?

Its one ancestor has a recall.
Of its descendants, K080192 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 20 descendants of its own.
6 other devices also cite its predicate K011093.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)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 Central Monitoring System is intended to conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors in hospitals or medical institutions, the monitoring parameters include ECG, NIBP, SpO2, PR, RESP, IBP, TEMP, C02 and AG. It is not intended for home use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062194: Hypervisor VI Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062194

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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