510(k) Report

510(k) · Cleared

Cleared

Tanita Segmental Body Composition Analyzer, Model BC-418

K033157510(k) TraditionalCleared Apr 8, 2004191-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 Apr 8, 2004 as substantially equivalent to K014009 (Tanita Corp. of America, 2002) after a 191-day review. Its family tree reaches back 2 generations to 1994. 15 later devices descend from it.

Decided
Apr 8, 2004
Review
191 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K930599 (1994). 15 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2011: 2 descendants cleared2007: 3 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2013: 2 descendants 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: 4 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 3 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 deviceK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita 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 · 2 generations on · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
  6. Descendant · 3 generations on · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
  7. Descendant · cites it directly · 4 of its ownK053556 Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006
  8. Descendant · 4 generations on · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006: 32007: 32008: 12009: 12010: 12011: 22013: 22014: 12015: 1
2006high 3 (2006) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all
  • K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America · 2006 · cites it directly7descendants
  • K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · 2 generations on6descendants
  • K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 3 generations on4descendants
  • K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006 · cites it directly4descendants
  • K110689InbodyBiospace Corporation Limited · 2011 · 4 generations on3descendants
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)K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America2004—
+1K062652Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorTanita Corporation of America2006—
+2K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited2007—
+3K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited2010—
+1K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd.2006—
+4K110689InbodyBiospace Corporation Limited2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200730
200810
200910
201010
201120
201320
201410
201510
FIG. 1 — Lineage of K033157, 1994–2015Source: 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
…tputs include BMR (basal metabolic rate), TBW (total body water), and BMI (body mass index). Predicate Device: TAN ITA Body Fat Analyzer Professional Model TBF-41 0 K0 14009 Scientific Concepts and Significant Performance Characteristics: Body Fat Analyzer…
Tanita Corp. of America2002—

Also cleared against K014009: 5 other devices →

What descends from it? (15)

See all 15

4 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
K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd.20064
K100183Model MC-180MA Multi-Frequency Body Composition AnalyzerTanita Corp.20110
K060848Bod PodLife Measurement, Inc.20060

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?

A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

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
  • 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
  • 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

  • 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
  • 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/K033157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033157: Tanita Segmental Body Composition Analyzer, Model BC-418.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033157

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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