510(k) · Cleared
ClearedVital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Biolight Meditech Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 1, 2012 as substantially equivalent to K101445 (Welch Allyn, Inc., 2010) and 3 other predicates after a 126-day review. Its family tree reaches back 15 generations to 1994. 3 later devices descend from it.
- Decided
- May 1, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K941811 (1994). 119 ancestors in all, the oldest K842616 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations between
- 3 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- This deviceK113833 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK153135 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK181919 Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK170538 RVS-100 Vital Signs MonitorRudolf Riester GmbH · 2017
Show all 15 generations
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 13 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 12 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 11 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 10 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 9 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 8 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 7 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 6 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 5 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 1 generation backK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- This deviceK113833 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −14 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −13 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −12 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −11 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −10 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −9 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −8 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −7 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −6 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −5 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −2 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −1 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| 0 (this device) | K113833 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2012 | — |
| +1 | K153135 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| +2 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | — |
| +2 | K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017 | — |
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 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 16 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K101445 | Vital Signs Monitor-VSM 6000 SeriesSummary page 3…other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use. 5. Predicate Device Identification 5 10(k) Number: K 10 1445 Product Name: Vital Signs Monitor - VSM 6000 Series Manufacturer: Welch Allyn, Inc. 5 10(k) Number: K4053 174… | 2010 |
| * | K053174 | Loflo C5 CO2 Sensor | 2006 |
| * | K103097 | Infrared Ear ThermometerSummary page 3…cturer: Welch Allyn, Inc. 5 10(k) Number: K4053 174 Product Name: LoFlo C5 C02 sensor Manufacturer: Respironics Novamnetrix, LLC 5 10O(k) Number: K 103097 Product Name: Infrared Ear Thermometer Manufacturer: Radiant Innovation Inc. 5 10O(k) Number: K 100046 Prod… | 2010 |
| * | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Summary page 3…pironics Novamnetrix, LLC 5 10O(k) Number: K 103097 Product Name: Infrared Ear Thermometer Manufacturer: Radiant Innovation Inc. 5 10O(k) Number: K 100046 Product Name: M66 Patient Monitor Manufacturer: Guangdong Biolight Meditech Co., Ltd 6. Device Description… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153135 | Vital Signs Monitor | 2016 | 2 |
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 18 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 19 of the 119 ancestors have a recall of any class.
- Of its descendants, K153135 (Guangdong Biolight Meditech Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K101445.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department. The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing…
Read the full statement (136 words)
The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.
The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (C02) and Temperature (Temp).
It is intended to be used in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113833: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113833
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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