510(k) · Cleared
ClearedBody Composition Analyzer, Model: Ioi 353
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 Oct 8, 2009 as substantially equivalent to K071884 (Jawon Medical Co., Ltd., 2007) after a 62-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Oct 8, 2009
- Review
- 62 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930599 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 4 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 3 generations backK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
- 2 generations backK053556 Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006
- 1 generation backK071884 Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus…Jawon Medical Co., Ltd. · 2007
- This deviceK092431 Body Composition Analyzer, Model: Ioi 353Jawon Medical Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK140045 Body Composition AnalyzerJawon Medical Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K140045Body Composition AnalyzerJawon Medical Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −4 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −3 | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418 | Tanita Corp. of America | 2004 | — |
| −2 | K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 | Jawon Medical Co., Ltd. | 2006 | — |
| −1 | K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis… | Jawon Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K092431 | Body Composition Analyzer, Model: Ioi 353 | Jawon Medical Co., Ltd. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia…Summary page 1…Body Composition Analyzer (impedance plethysmograph) I MNW Predicate Device: Body Composition Analyzer Models GAlA 359 PLUS and XBIA 500 (K071 884) Device Description: The ioi 353 is body composition analyzer is intended for use only in healthy… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140045 | Body Composition Analyzer | 2015 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140045 (Jawon Medical Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
This device is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
This devices is intended for use only in healthy subjects between the age of 7-89.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092431: Body Composition Analyzer, Model: Ioi 353.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092431
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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