510(k) · Cleared
ClearedInnerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor
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 Dec 28, 2006 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Dec 28, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930599 (1994). 4 ancestors in all. 7 later devices descend from it, 1 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 backK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
- This deviceK062652 Innerscan Body Composition Monitor, Innerscan Segmental Body…Tanita Corporation of America · 2006
- Descendant · cites it directly · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- Descendant · 2 generations on · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
- Descendant · 3 generations on · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011
- Descendant · 4 generations on · 2 of its ownK123228 Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013
- Descendant · 4 generations on · 0 of its ownK141483 Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · cites it directly6descendants
- K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 2 generations on4descendants
- K110689InbodyBiospace Corporation Limited · 2011 · 3 generations on3descendants
- K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013 · 4 generations on2descendants
- K141483Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014 · 4 generations on0descendants
View 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 | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418 | Tanita Corp. of America | 2004 | — |
| 0 (this device) | K062652 | Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor | Tanita Corporation of America | 2006 | — |
| +1 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| +2 | K092786 | Inbody, Models: 270, R20, R20B | Biospace Corporation Limited | 2010 | — |
| +3 | K110689 | Inbody | Biospace Corporation Limited | 2011 | — |
| +4 | K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) | Biospace Corporation Limited | 2013 | — |
| +4 | K141483 | Biospace Body Composition Analyzer | Biospace Corporation Limited | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Summary page 1…lthy range, basalI metabolic rate (BMR), daily caloric intake (DCI) and metabolic age. Predicate Devices: TANITA Body Fat Analyzer Professional and Consumer Models K040778 and K033157 Scientific Concepts and Significant Performance Characteristics: 'Same as shown in SECTIONS9. and APPENDIX I. (… | 2004 |
| * | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418Summary page 1…basalI metabolic rate (BMR), daily caloric intake (DCI) and metabolic age. Predicate Devices: TANITA Body Fat Analyzer Professional and Consumer Models K040778 and K033157 Scientific Concepts and Significant Performance Characteristics: 'Same as shown in SECTIONS9. and APPENDIX I. (Substantial… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | 2007 | 6 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062603 (Biospace Corporation Limited, 2007) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K040778.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and…
Read the full statement (136 words)
The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062652: Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062652
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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