510(k) Report

510(k) · Cleared

Cleared

Body Composition Analyzer, Easybody 202, 203, 205

K072325510(k) TraditionalCleared Nov 30, 2007102-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

Jawon Medical Co., Ltd. · MNW Analyzer, Body Composition

Cleared on Nov 30, 2007 as substantially equivalent to K053556 (Jawon Medical Co., Ltd., 2006) after a 102-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.

Decided
Nov 30, 2007
Review
102 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K930599 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 4 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
  2. 3 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
  3. 2 generations backK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
  4. 1 generation backK053556 Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006
  5. This deviceK072325 Body Composition Analyzer, Easybody 202, 203, 205Jawon Medical Co., Ltd. · 2007
  6. Descendant · cites it directly · 0 of its ownK140045 Body Composition AnalyzerJawon Medical Co., Ltd. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K140045Body Composition AnalyzerJawon Medical Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K930599Body Fat Analyzer Model TBF-105Tanita Corp. of America1994—
−3K014009Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleTanita Corp. of America2002—
−2K033157Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America2004—
−1K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd.2006—
0 (this device)K072325Body Composition Analyzer, Easybody 202, 203, 205Jawon Medical Co., Ltd.2007—
+1K140045Body Composition AnalyzerJawon Medical Co., Ltd.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K072325, 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
*K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5
Summary page 1
…dy Composition Monitor Classification Name: Body Composition Analyzer (Impedance plethysmograph) / MNW Predicate Device: Body Composition Analyzer Model ZEUS 9.9 (K053556) Device Description: The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body compositio…
Jawon Medical Co., Ltd.2006—

Also cleared against K053556: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140045Body Composition AnalyzerJawon Medical Co., Ltd.20150

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 13 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K140045 (Jawon Medical Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K053556.

How does its category compare?

All MNW devices

MNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method. The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM…

Read the full statement (115 words)

The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 202, EasyBody 203 and EasyBody 205; measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072325: Body Composition Analyzer, Easybody 202, 203, 205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072325

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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