510(k) · Cleared
ClearedBody Composition Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jawon Medical Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Feb 18, 2015 as substantially equivalent to K092431 (Jawon Medical Co., Ltd., 2009) and 1 other predicate after a 406-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Feb 18, 2015
- Review
- 406 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930599 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 5 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 4 generations backK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
- 3 generations backK053556 Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006
- 2 generations backK071884 Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus…Jawon Medical Co., Ltd. · 2007
- 1 generation backK092431 Body Composition Analyzer, Model: Ioi 353Jawon Medical Co., Ltd. · 2009
- This deviceK140045 Body Composition AnalyzerJawon Medical Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −5 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −4 | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418 | Tanita Corp. of America | 2004 | — |
| −3 | K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 | Jawon Medical Co., Ltd. | 2006 | — |
| −2 | K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis… | Jawon Medical Co., Ltd. | 2007 | — |
| −1 | K092431 | Body Composition Analyzer, Model: Ioi 353 | Jawon Medical Co., Ltd. | 2009 | — |
| 0 (this device) | K140045 | Body Composition Analyzer | Jawon Medical Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 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 MNW? 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 MNW device
- #1 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
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 |
|---|---|---|---|
| * | K092431 | Body Composition Analyzer, Model: Ioi 353Summary page 5…Body Composition Monitor Classification Name: Body Composition Analyzer (Impedance plethysmograph) /MNW Predicate Device: Body Composition Analyzer Models ioi 353{K092431) and EasyBody 202(K072325) A list of 510(k) X-Contact 350, X-Contact 350M, X-Contact 350S Devices To B… | 2009 |
| * | K072325 | Body Composition Analyzer, Easybody 202, 203, 205Summary page 5…dy Composition Analyzer (Impedance plethysmograph) /MNW Predicate Device: Body Composition Analyzer Models ioi 353{K092431) and EasyBody 202(K072325) A list of 510(k) X-Contact 350, X-Contact 350M, X-Contact 350S Devices To Be Cleared No. Model Name Indication for… | 2007 |
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 21 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter. In case of whole body, it shows more items…
Read the full statement (123 words)
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140045: Body Composition Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140045
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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