510(k) · Cleared
ClearedWithings, Smart Body Scale
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhongshan Transtek Electronics Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Sep 27, 2012 as substantially equivalent to K102191 (Zhongshan Transtek Electronics Co., Ltd., 2011) after an 84-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Sep 27, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930599 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 4 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 3 generations backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- 2 generations backK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
- 1 generation backK102191 Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek…Zhongshan Transtek Electronics Co., Ltd. · 2011
- This deviceK121971 Withings, Smart Body ScaleZhongshan Transtek Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK133872 Aria Wifi Smart ScaleFitbit, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133872Aria Wifi Smart ScaleFitbit, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −4 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −3 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K121971 | Withings, Smart Body Scale | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| +1 | K133872 | Aria Wifi Smart Scale | Fitbit, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102191 | Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body…Summary page 1…ications: Do not use the Body Scale if you have a pacemaker or other internal medical device. 4. The Predicate Devices 1'RANSTE.K, Glass Body Analyzer, Model GBF-830, K 102191 5. Device lDescription -5.1 Technology of the device: lBioelectrical Impedance:- WBSO I Smart Body Scale uses the BIA (Bioel… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133872 | Aria Wifi Smart Scale | 2014 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133872 (Fitbit, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102191.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Withings WBSO1 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat 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/K121971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121971: Withings, Smart Body Scale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121971
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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