510(k) · Cleared
ClearedMulti-parameter detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Jun 15, 2024 as substantially equivalent to K222979 (Microlife Intellectual Property GmbH, 2023) and 1 other predicate after a 422-day review. Its family tree reaches back 14 generations to 1994. 1 of the 147 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 15, 2024
- Review
- 422 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K941811 (1994). 146 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 147 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations between
- 3 generations backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- 2 generations backK170047 All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017
- 1 generation backK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- This deviceK231116 Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024
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 backK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- 3 generations backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- 2 generations backK170047 All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017
- 1 generation backK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- This deviceK231116 Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
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 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
| −3 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | — |
| −2 | K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017 | — |
| −1 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| 0 (this device) | K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 5 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 1 |
| 1998 | 14 | 0 |
| 1999 | 12 | 0 |
| 2000 | 12 | 0 |
| 2001 | 2 | 0 |
| 2002 | 9 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W Cleared while this submission was under review Summary page 6…A/0 3. Primary Predicate Device Trade Name Microlife Upper Arm Automatic Digital Blood Pressure Monitor 510(k) Number K222979 Product Code DXN Regulation No. 21 CFR 870.1130 Manufacturer Microlife Intellectual Property… | 2023 |
| * | K210086 | Vitals360 Multi-Vitals Mobile MonitorSummary page 6…Manufacturer Microlife Intellectual Property GmbH 4. Secondary Predicate Device Trade Name Vitals360® Multi-Vitals Mobile Monitor 510(k) Number K210086 Product Code MWI Subsequent Product DQA, DSH DXN, FLL Codes Regu… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 18 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K222979.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MNW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNW
110in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNW
No recall names MNW since 2007.
Adverse event reports per year · MNW
3in 2024
MAUDE reports naming product code MNW, 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 | 4 | 109 | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 137 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 11 | 168 | 0 | 0 |
| 2012 | 4 | 103 | 0 | 0 |
| 2013 | 9 | 144 | 0 | 0 |
| 2014 | 3 | 110 | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, visceral fat grade, basal metabolism and free fat mass (muscle mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231116: Multi-parameter detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231116
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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