510(k) Report

510(k) · Cleared

Cleared

Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale

K014009510(k) TraditionalCleared Jun 24, 2002201-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 Jun 24, 2002 as substantially equivalent to K930599 (Tanita Corp. of America, 1994) after a 201-day review. Its family tree reaches back 1 generation to 1994. 38 later devices descend from it.

Decided
Jun 24, 2002
Review
201 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K930599 (1994). 38 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 3 descendants cleared2011: 7 descendants cleared2009: 3 descendants cleared2008: 2 descendants cleared2006: 4 descendants cleared2012: 4 descendants cleared2013: 6 descendants cleared2014: 3 descendants cleared2007: 3 descendants cleared2010: 1 descendant cleared2015: 1 descendant clearedK930599 · Body Fat Analyzer Model TBF-105 · Tanita Corp. of America · 19941990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants K930599 · Body Fat Analyzer Model TBF-105 · Tanita Corp. of America · 19940+5
  1. Root · 1 generation backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
  2. This deviceK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
  3. Descendant · cites it directly · 27 of its ownK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
  4. Descendant · cites it directly · 15 of its ownK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
  5. Descendant · 2 generations on · 7 of its ownK062652 Innerscan Body Composition Monitor, Innerscan Segmental Body…Tanita Corporation of America · 2006
  6. Descendant · 2 generations on · 6 of its ownK083838 Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009
  7. Descendant · 3 generations on · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2003: 12004: 32006: 42007: 32008: 22009: 32010: 12011: 72012: 42013: 62014: 32015: 1
2003high 7 (2011) · low 0 (2005)2026

Most influential descendants

Showing 5 of 38 · See all
  • K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America · 2004 · cites it directly27descendants
  • K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004 · cites it directly15descendants
  • K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America · 2006 · 2 generations on7descendants
  • K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited · 2009 · 2 generations on6descendants
  • K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930599Body Fat Analyzer Model TBF-105Tanita Corp. of America1994—
0 (this device)K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America2002—
+1K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America2004—
+1K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America2004—
+2K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America2006—
+2K083838Scaleman Body Fat Scales, Model: FS-148BW1 SeriesFook Tin Technologies Limited2009—
+3K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
200640
200730
200820
200930
201010
201170
201240
201360
201430
201510
FIG. 1 — Lineage of K014009, 1994–2015Source: 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
*K930599Body Fat Analyzer Model TBF-105
Summary page 1
…estimates body fat composition with the use of BIA (bioelectrical impedance analysis). Predicate Device: TANITA Body Fat Analyzer Model TBF-105 K930599 Scientific Concepts and Significant Performance Characteristics:…
Tanita Corp. of America1994—

Also cleared against K930599: 1 other device →

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America200427
K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America200415
K090479Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America20092
K030349Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960Bonso Electronics International, Inc.20031
K103058Multifunction KeitoAguiflai Iberica S.L.20110
K040978Tanita Scale Plus Body Fat Monitor with Body Water PercentageTanita Corp. of America20040

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?

  • Its one ancestor has no recall.
  • Of its descendants, K040778 (Tanita Corp. of America, 2004) has gone furthest, with 27 descendants of its own.
  • 1 other device also cites its predicate K930599.

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?

MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350:

A body composition analyzer that measures body weight and impedance and estimates body fat percent, BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis).

MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001:

A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).

Indications for use as stated in the FDA summary.

Also cleared against K930599

1 other device cites the same predicate.

  • K023478Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003

More from Tanita Corp. of America

6 FDA decisions under this applicant name. See the company

  • K040778Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Tanita Corp. of America · 2004
  • 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
  • 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/K014009 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014009: Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014009

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026