510(k) Report

510(k) · Cleared

Cleared

Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)

K040778510(k) TraditionalCleared Dec 23, 2004272-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

Tanita Corp. of America · MNW Analyzer, Body Composition

Cleared on Dec 23, 2004 as substantially equivalent to K014009 (Tanita Corp. of America, 2002) after a 272-day review. Its family tree reaches back 2 generations to 1994. 27 later devices descend from it.

Decided
Dec 23, 2004
Review
272 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K930599 (1994). 27 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2011: 6 descendants cleared2012: 4 descendants cleared2013: 6 descendants cleared2008: 2 descendants cleared2014: 3 descendants cleared2009: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant clearedK930599 · Body Fat Analyzer Model TBF-105 · Tanita Corp. of America · 1994K014009 · Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale · Tanita Corp. of America · 20021990200020102020
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants K014009 · Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale · Tanita Corp. of America · 2002K930599 · Body Fat Analyzer Model TBF-105 · Tanita Corp. of America · 19940+5
  1. Root · 2 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
  2. 1 generation backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
  3. This deviceK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
  4. Descendant · cites it directly · 7 of its ownK062652 Innerscan Body Composition Monitor, Innerscan Segmental Body…Tanita Corporation of America · 2006
  5. Descendant · cites it directly · 6 of its ownK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
  6. Descendant · 2 generations on · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
  7. Descendant · 2 generations on · 5 of its ownK102191 Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek…Zhongshan Transtek Electronics Co., Ltd. · 2011
  8. Descendant · 3 generations on · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 22009: 22010: 12011: 62012: 42013: 62014: 3
2006high 6 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 27 · See all
  • K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America · 2006 · cites it directly7descendants
  • K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009 · cites it directly6descendants
  • K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · 2 generations on6descendants
  • K102191Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body…Zhongshan Transtek Electronics Co., Ltd. · 2011 · 2 generations on5descendants
  • K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930599Body Fat Analyzer Model TBF-105Tanita Corp. of America1994—
−1K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America2002—
0 (this device)K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America2004—
+1K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America2006—
+1K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited2009—
+2K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited2007—
+2K102191Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass…Zhongshan Transtek Electronics Co., Ltd.2011—
+3K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200820
200920
201010
201160
201240
201360
201430
FIG. 1 — Lineage of K040778, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale
Summary page 1
…intake), bone mass, visceral fat rating, metabolic age, physique rating and muscle mass. Predicate Devices: TANITA Body Fat Analyzer Professional and Consumer Models K014009 Page 13…
Tanita Corp. of America2002—

Also cleared against K014009: 5 other devices →

What descends from it? (27)

See all 27

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America20067
K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited20096
K110928Body Analysis Scale, Model BG 17Shenzhen Healthcare Electronic Technology Co., Ltd.20112
K090479Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America20092
K140594Body Fat Analyzer and ScaleConmo Electronic Company Limited20140
K122976Body Fat Scale Model SF-371Shenzhen Belter Health Measurement and Analysis TE20130
K112149Weight and Body Fat Scale Shine BS0105Shine Overseas Marketing Limited20120
K111404Huibao Body Fat ScaleZhongshan Huibao Weighing Apparatus Co., Ltd.20110
K081587Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530Krell Precision (Yang Zhou) Co., Ltd.20080
K060538Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568Beaverite International Limited20060

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 10 years and passes through 1 company; a new generation was cleared every 7.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K062652 (Tanita Corporation of America, 2006) has gone furthest, with 7 descendants of its own.
  • 5 other devices also cite its predicate K014009.

How does its category compare?

All MNW devices

MNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 TANiTA family of InnerScan Body Composition Monitors measure body weight and impedance and estimate percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 7-17 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.

Also cleared against K014009

5 other devices cite the same predicate.

  • K103058Multifunction KeitoAguiflai Iberica S.L. · 2011
  • K090479Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America · 2009
  • K040978Tanita Scale Plus Body Fat Monitor with Body Water PercentageTanita Corp. of America · 2004
  • K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
  • K030349Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960Bonso Electronics International, Inc. · 2003

More from Tanita Corp. of America

6 FDA decisions under this applicant name. See the company

  • K040978Tanita Scale Plus Body Fat Monitor with Body Water PercentageTanita Corp. of America · 2004
  • K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
  • K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America · 2002
  • K930599Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
  • K932572Digital Baby Scale Model BLB-12Tanita Corp. of America · 1993

Recent decisions in MNW

The MNW category page

  • K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024
  • K140045Body Composition AnalyzerJawon Medical Co., Ltd. · 2015
  • K141483Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
  • K133872Aria Wifi Smart ScaleFitbit, Inc. · 2014
  • K140594Body Fat Analyzer and ScaleConmo Electronic Company Limited · 2014

https://510kreport.com/device/K040778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040778: Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040778

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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