510(k) · Cleared
ClearedScaleman Body Fat Scales, Model: FS-148BW1 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fook Tin Technologies Limited · MNW Analyzer, Body Composition
Cleared on May 12, 2009 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) after a 140-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- May 12, 2009
- Review
- 140 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930599 (1994). 6 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 backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- This deviceK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
- Descendant · cites it directly · 5 of its ownK102191 Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek…Zhongshan Transtek Electronics Co., Ltd. · 2011
- Descendant · 2 generations on · 2 of its ownK112932 TranstekZhongshan Transtek Electronics Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK123781 Transtek Glass Body Fat AnalyzerZhongshan Transtek Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK121971 Withings, Smart Body ScaleZhongshan Transtek Electronics Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK133872 Aria Wifi Smart ScaleFitbit, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102191Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body…Zhongshan Transtek Electronics Co., Ltd. · 2011 · cites it directly5descendants
- K112932TranstekZhongshan Transtek Electronics Co., Ltd. · 2011 · 2 generations on2descendants
- K123781Transtek Glass Body Fat AnalyzerZhongshan Transtek Electronics Co., Ltd. · 2013 · 3 generations on1descendant
- K121971Withings, Smart Body ScaleZhongshan Transtek Electronics Co., Ltd. · 2012 · 2 generations on1descendant
- K133872Aria Wifi Smart ScaleFitbit, Inc. · 2014 · 3 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 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| 0 (this device) | K083838 | Scaleman Body Fat Scales, Model: FS-148BW1 Series | Fook Tin Technologies Limited | 2009 | — |
| +1 | 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 | — |
| +3 | K123781 | Transtek Glass Body Fat Analyzer | Zhongshan Transtek Electronics Co., Ltd. | 2013 | — |
| +2 | K121971 | Withings, Smart Body Scale | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| +3 | K133872 | Aria Wifi Smart Scale | Fitbit, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Summary page 1…Classification Number: 21 CFR 870.2770 Product code: MNW Predicate Device: Tanita Innerscan Body Composition Monitor, K040778 Statement of Intended Use: The Scaleman Body Fat Scales - Models in 'Family Model List 1A" is… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102191 | Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body… | 2011 | 5 |
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 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102191 (Zhongshan Transtek Electronics Co., Ltd., 2011) has gone furthest, with 5 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. 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?
Family Model List 1A A series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Family Model List lB A series of body composition analyzers that…
Read the full statement (123 words)
Family Model List 1A
A series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, using BIA (bioelectrical impedance analysis).
They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Family Model List lB
A series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis).
They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083838: Scaleman Body Fat Scales, Model: FS-148BW1 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083838
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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