510(k) · Cleared
ClearedBody Fat Analyzer Model TBF-105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tanita Corp. of America · DSB Plethysmograph, Impedance
Cleared on Nov 1, 1994 after a 634-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 43 later devices descend from it.
- Decided
- Nov 1, 1994
- Review
- 634 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 2 citing it directly.
- This deviceK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- Descendant · cites it directly · 38 of its ownK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- Descendant · 2 generations on · 27 of its ownK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- Descendant · 2 generations on · 15 of its ownK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
- Descendant · cites it directly · 11 of its ownK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- Descendant · 2 generations on · 10 of its ownK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America · 2002 · cites it directly38descendants
- K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America · 2004 · 2 generations on27descendants
- K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004 · 2 generations on15descendants
- K023478Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003 · cites it directly11descendants
- K042528Inbody, Model 3.0Biospace Corporation Limited · 2005 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| +1 | 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 | — |
| +2 | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418 | Tanita Corp. of America | 2004 | — |
| +1 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| +2 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSB? 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 DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (43)
See all 432 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?
- Of its descendants, K014009 (Tanita Corp. of America, 2002) has gone furthest, with 38 descendants of its own.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, 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 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K930599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930599: Body Fat Analyzer Model TBF-105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930599
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026