510(k) Report

510(k) · Cleared

Cleared

Inbody, Models: 270, R20, R20B

K092786510(k) TraditionalCleared Mar 10, 2010181-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

Biospace Corporation Limited · MNW Analyzer, Body Composition

Cleared on Mar 10, 2010 as substantially equivalent to K062603 (Biospace Corporation Limited, 2007) after a 181-day review. Its family tree reaches back 5 generations to 1983. 4 later devices descend from it.

Decided
Mar 10, 2010
Review
181 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K830292 (1983). 13 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2004: 2 other ancestors2001: 2 other ancestors2002: 1 other ancestor1994: 1 other ancestor2011: 1 descendant cleared2014: 1 descendant cleared2013: 2 descendants clearedK830292 · Bioelectrical Impedance Analyzer #101 · Rjl Systems, Inc. · 1983K023478 · Inbody AP1 Body Composition Analyzer · Biospace Co.,Ltd · 2003K042528 · Inbody, Model 3.0 · Biospace Corporation Limited · 2005K052646 · Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 · Biospace Corporation Limited · 2005K062603 · Biospace Body Composition Analyzers, Model Inbody 230 · Biospace Corporation Limited · 200719801990200020102020
  1. Root · 5 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
  2. 4 generations backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
  3. 3 generations backK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
  4. 2 generations backK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
  5. 1 generation backK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
  6. This deviceK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
  7. Descendant · cites it directly · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011
  8. Descendant · 2 generations on · 2 of its ownK123228 Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013
  9. Descendant · 2 generations on · 0 of its ownK141483 Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
  10. Descendant · 2 generations on · 0 of its ownK130777 InbodyBiospace Corporation Limited · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K110689InbodyBiospace Corporation Limited · 2011 · cites it directly3descendants
  • K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013 · 2 generations on2descendants
  • K141483Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014 · 2 generations on0descendants
  • K130777InbodyBiospace Corporation Limited · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K830292Bioelectrical Impedance Analyzer #101Rjl Systems, Inc.1983—
−4K023478Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd2003—
−3K042528Inbody, Model 3.0Biospace Corporation Limited2005—
−2K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited2005—
−1K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited2007—
0 (this device)K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited2010—
+1K110689InbodyBiospace Corporation Limited2011—
+2K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited2013—
+2K141483Biospace Body Composition AnalyzerBiospace Corporation Limited2014—
+2K130777InbodyBiospace Corporation Limited2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200120
200210
200420
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201410
FIG. 1 — Lineage of K092786, 1983–2014Source: 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
*K062603Biospace Body Composition Analyzers, Model Inbody 230
Summary page 1
…s: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 230 K062603 3. Indications for Use (intended use) For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, E…
Biospace Corporation Limited2007—

Also cleared against K062603: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K110689InbodyBiospace Corporation Limited20113

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 27 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K110689 (Biospace Corporation Limited, 2011) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K062603.

How does its category compare?

All MNW devices

MNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

For use only in healthy subjects for Measurement Of:

Estimated:

Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water, (TRW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Eat mass, % Segmental Body Fat, and Energy expenditure of activity.

Actual: Weight, Body Mass Index (BMI),and Impedance Values

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K092786: Inbody, Models: 270, R20, R20B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092786

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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