510(k) · Cleared
ClearedTranstek Glass Body Fat Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Transtek Medical Electronics Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Sep 18, 2013 as substantially equivalent to K123781 (Zhongshan Transtek Electronics Co., Ltd., 2013) after a 126-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 18, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930599 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 6 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 5 generations backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- 4 generations backK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
- 3 generations backK102191 Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek…Zhongshan Transtek Electronics Co., Ltd. · 2011
- 2 generations backK112932 TranstekZhongshan Transtek Electronics Co., Ltd. · 2011
- 1 generation backK123781 Transtek Glass Body Fat AnalyzerZhongshan Transtek Electronics Co., Ltd. · 2013
- This deviceK131394 Transtek Glass Body Fat AnalyzerGuangdong Transtek Medical Electronics Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −6 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −5 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| −4 | K083838 | Scaleman Body Fat Scales, Model: FS-148BW1 Series | Fook Tin Technologies Limited | 2009 | — |
| −3 | K102191 | Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass… | Zhongshan Transtek Electronics Co., Ltd. | 2011 | — |
| −2 | K112932 | Transtek | Zhongshan Transtek Electronics Co., Ltd. | 2011 | — |
| −1 | K123781 | Transtek Glass Body Fat Analyzer | Zhongshan Transtek Electronics Co., Ltd. | 2013 | — |
| 0 (this device) | K131394 | Transtek Glass Body Fat Analyzer | Guangdong Transtek Medical Electronics Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K123781 | Transtek Glass Body Fat AnalyzerSummary page 1…tion Analyzer/Scales Product Code: MNW Regulation No.: 870.2770 Device Classification: Class 11 4. The Predicate Devices TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781 Section 6- 510(k) Summary Page I of… | 2013 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Transtek Glass Body Fat Analyzer measure weight and uses bicelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.
It is intended for use in the home/domestic setting only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131394: Transtek Glass Body Fat Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131394
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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