510(k) · Cleared
ClearedMulti-parameter Patient Monitor, models C30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Comen Medical Instruments Co.,Ltd · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Aug 16, 2018 as substantially equivalent to K123074 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2013) and 1 other predicate after a 283-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Aug 16, 2018
- Review
- 283 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K941811 (1994). 105 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations between
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK112877 Comen Multi-Parameter Patient MonitorGoldway (Us), Inc. · 2012
- This deviceK173454 Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd · 2018
Show all 14 generations
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 12 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 11 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 10 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 9 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 8 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 7 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 6 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 5 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 4 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK112877 Comen Multi-Parameter Patient MonitorGoldway (Us), Inc. · 2012
- This deviceK173454 Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −13 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −12 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −11 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −10 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −9 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −8 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −7 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −6 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −5 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −4 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −1 | K112877 | Comen Multi-Parameter Patient Monitor | Goldway (Us), Inc. | 2012 | — |
| 0 (this device) | K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K123074 | Imec, Ipm and Beneview T1 Patient MonitorsSummary page 5…DSB Plethysmograph, Impedance General Hospital §880 .2910, II FLL Thermometer, Electronic, Clinical Predicate Devices: K123074, BeneView T1 Patient monitor, Shenzhen Mindray Bio-medical Electronics (The primary predicate device)… | 2013 |
| * | K112877 | Comen Multi-Parameter Patient MonitorSummary page 5…evices: K123074, BeneView T1 Patient monitor, Shenzhen Mindray Bio-medical Electronics (The primary predicate device) K112877, C80 COMEN Multi-parameter Patient Monitor, Shenzhen Comen Medical Instruments Co., Ltd Device descripti… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 8 companies; a new generation was cleared every 5 months on median.
- 14 of the 105 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123074.
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 | — |
What is it indicated for?
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It’s used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters…
Read the full statement (108 words)
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It’s used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.
The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173454: Multi-parameter Patient Monitor, models C30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173454
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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