510(k) · Cleared
ClearedTruscope Series Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Biolight Meditech Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 15, 2013 as substantially equivalent to K120193 (Guangdong Biolight Meditech Co., Ltd., 2012) and 2 other predicates after a 28-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Jul 15, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K941811 (1994). 93 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.
- Root · 16 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations between
- 3 generations backK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- 1 generation backK102040 Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2010
- This deviceK131763 Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2013
Show all 16 generations
- Root · 16 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 15 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 14 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 13 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 12 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 11 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 10 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 9 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 8 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 7 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 6 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 5 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 3 generations backK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- 1 generation backK102040 Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2010
- This deviceK131763 Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −15 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −14 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −13 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −12 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −11 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −10 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −9 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −8 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −7 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −6 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −5 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −3 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −2 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| −1 | K102040 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| 0 (this device) | K131763 | Truscope Series Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K120193 | Any View Patient MonitorsSummary page 3…er the direction of physicians. They are not intended for helicopter transport or hospital ambulance. 5. Predicate Device Identification 5 10(k) Number: K 120193 111-3… | 2012 |
| * | K102040 | Patient MonitorSummary page 4…IENT MONITORS ANY VIEW A6. ANY VIEW A8. ANYVIEW A3, ANY VIEW AS Manufacturer: Guangdong Biolight Meditech Co., Ltd 510(k) Number: K 102040 *Predicate Device Name: PATIENT MONITOR ANY VI EW A6, ANY VIEW All, M9500 Manufacturer: Guangdong Biolight Meditech Co.,… | 2010 |
| * | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Summary page 4…umber: K 102040 *Predicate Device Name: PATIENT MONITOR ANY VI EW A6, ANY VIEW All, M9500 Manufacturer: Guangdong Biolight Meditech Co., Ltd 510(k) Number: K 100046 Predicate Device Name: M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 Manufac… | 2010 |
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 19 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 10 of the 93 ancestors have a recall of any class.
- 1 other device also cites its predicate K120193.
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 Truscope series patient monitors (Truscope Elite AS, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) 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, ST segment analysis, Heart Rate (HIR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR)…
Read the full statement (328 words)
The Truscope series patient monitors (Truscope Elite AS, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) 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, ST segment analysis, Heart Rate (HIR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (C02), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI).
The arrhythmia detection, ST segment analysis only applied to a single adult patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.
Truescope Series Patient Monitor (Truscope 11 and MINT) is intended to be used for monitoring,, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (H-R), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (JBP), carbon dioxide (C02), and Temperature (TEMP) of adult, pediatric and neonatal patient.
Truescope Series Patient Monitor (Truscope 11 and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide
Trnaescopc Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including 2CQ] Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (C02), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131763: Truscope Series Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131763
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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