510(k) · Cleared
ClearedModel MC-180MA Multi-Frequency Body Composition Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tanita Corp. · MNW Analyzer, Body Composition
Cleared on Apr 15, 2011 as substantially equivalent to K033157 (Tanita Corp. of America, 2004) and 2 other predicates after a 449-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 15, 2011
- Review
- 449 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930599 (1994). 10 ancestors in all, the oldest K830292 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 3 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 2 generations backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- 1 generation backK090479 Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America · 2009
- This deviceK100183 Model MC-180MA Multi-Frequency Body Composition AnalyzerTanita Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −3 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −2 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| −1 | K090479 | Tanita Body Composition Analyzer, Model SC-331 | Tanita Corporation of America | 2009 | — |
| 0 (this device) | K100183 | Model MC-180MA Multi-Frequency Body Composition Analyzer | Tanita Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418Summary page 1…Product Code: MNW 3. Predicate devices to claim substantial equivalence: a. Tanita Model BC-418 Segmental Body Composition Analyzer-K033 157 b. Biospace Model InBody 3.0 Body Composition Analyzer-K042528 c. Tanita Model SC-331 Body Composition Analyz… | 2004 |
| * | K042528 | Inbody, Model 3.0Summary page 1…substantial equivalence: a. Tanita Model BC-418 Segmental Body Composition Analyzer-K033 157 b. Biospace Model InBody 3.0 Body Composition Analyzer-K042528 c. Tanita Model SC-331 Body Composition Analyzer-K090479 4. Description of the Device: The Tanita Model MC-… | 2005 |
| * | K090479 | Tanita Body Composition Analyzer, Model SC-331Summary page 1…al Body Composition Analyzer-K033 157 b. Biospace Model InBody 3.0 Body Composition Analyzer-K042528 c. Tanita Model SC-331 Body Composition Analyzer-K090479 4. Description of the Device: The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a compute… | 2009 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K033157.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (PFM), 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.
For subjects 17 years old and younger, only fat % is displayed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100183: Model MC-180MA Multi-Frequency Body Composition Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100183
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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