510(k) Report

510(k) · Cleared

Cleared

Aria Wifi Smart Scale

K133872510(k) TraditionalCleared Jun 2, 2014164-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fitbit, Inc. · MNW Analyzer, Body Composition

Cleared on Jun 2, 2014 as substantially equivalent to K121971 (Zhongshan Transtek Electronics Co., Ltd., 2012) after a 164-day review. Its family tree reaches back 6 generations to 1994.

Decided
Jun 2, 2014
Review
164 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K930599 (1994). No later device cites it as a predicate yet.

  1. Root · 6 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
  2. 5 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
  3. 4 generations backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
  4. 3 generations backK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
  5. 2 generations backK102191 Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek…Zhongshan Transtek Electronics Co., Ltd. · 2011
  6. 1 generation backK121971 Withings, Smart Body ScaleZhongshan Transtek Electronics Co., Ltd. · 2012
  7. This deviceK133872 Aria Wifi Smart ScaleFitbit, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K930599Body Fat Analyzer Model TBF-105Tanita Corp. of America1994—
−5K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America2002—
−4K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America2004—
−3K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited2009—
−2K102191Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass…Zhongshan Transtek Electronics Co., Ltd.2011—
−1K121971Withings, Smart Body ScaleZhongshan Transtek Electronics Co., Ltd.2012—
0 (this device)K133872Aria Wifi Smart ScaleFitbit, Inc.2014—
FIG. 1 — Lineage of K133872, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K121971Withings, Smart Body Scale
Summary page 1
…Class 11 Substantial Equivalence This 510(k) submission demonstrates that the ARIA WiFi Smart Scale is substantially equivalent to the Smart Body Scale (Withings, K1 21 971) in both technology and intended use. Feature ARIA WiFi Smart Scale Withings Smart Body Sca…
Zhongshan Transtek Electronics Co., Ltd.2012—

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 20 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
  • None of the 6 ancestors has a recall.

How does its category compare?

All MNW devices

MNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MNW

1in 2024

2007: 42008: 42009: 42010: 12011: 112012: 42013: 92014: 32015: 12024: 1
2007high 11 (2011) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNW

110in 2014

2007: 109 days median2008: 134 days median2009: 137 days median2011: 168 days median2012: 103 days median2013: 144 days median2014: 110 days median
2007high 168 (2011) · low 103 (2012)2026

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

2010: 12015: 22016: 152017: 62018: 162019: 112020: 122021: 102022: 82023: 22024: 3
2007high 16 (2018) · low 0 (2007)2025

MAUDE reports naming product code MNW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007410900
2008413400
2009413700
20101—01
20111116800
2012410300
2013914400
2014311000
20151—02
20160—015
20170—06
20180—016
20190—011
20200—012
20210—010
20220—08
20230—02
20241—03
20250—00
20260—0—

What is it indicated for?

The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K133872: Aria Wifi Smart Scale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133872

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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