510(k) · Cleared
ClearedTanita Body Composition Analyzer, Model SC-331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tanita Corporation of America · MNW Analyzer, Body Composition
Cleared on Jul 7, 2009 as substantially equivalent to K014009 (Tanita Corp. of America, 2002) and 1 other predicate after a 133-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 7, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930599 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 2 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 1 generation backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- This deviceK090479 Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America · 2009
- Descendant · cites it directly · 0 of its ownK130952 Precision One Lifecare; Detecto; DetectoPrecision One Lifecare, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK100183 Model MC-180MA Multi-Frequency Body Composition AnalyzerTanita Corp. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −2 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −1 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| 0 (this device) | K090479 | Tanita Body Composition Analyzer, Model SC-331 | Tanita Corporation of America | 2009 | — |
| +1 | K130952 | Precision One Lifecare; Detecto; Detecto | Precision One Lifecare, Ltd. | 2013 | — |
| +1 | K100183 | Model MC-180MA Multi-Frequency Body Composition Analyzer | Tanita Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleSummary page 1…old and healthy adults with active, moderately active, to inactive lifestyles. Predicate Devices: TANITA Body Fat Analyzer Professional and Consumer Models K014009 and K040778. Scientific Concepts and Significant Performance Characteristics: 'Same as shown in SECTION 9. and APPEN… | 2002 |
| * | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Summary page 1…lthy adults with active, moderately active, to inactive lifestyles. Predicate Devices: TANITA Body Fat Analyzer Professional and Consumer Models K014009 and K040778. Scientific Concepts and Significant Performance Characteristics: 'Same as shown in SECTION 9. and APPENDIX 1. (Subs… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130952 (Precision One Lifecare, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K014009.
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?
The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).
The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090479: Tanita Body Composition Analyzer, Model SC-331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090479
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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