510(k) Report

510(k) · Cleared

Cleared

Inbody AP1 Body Composition Analyzer

K023478510(k) TraditionalCleared May 13, 2003209-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 Co.,Ltd · MNW Analyzer, Body Composition

Cleared on May 13, 2003 as substantially equivalent to K002835 (Bodystat, Ltd., 2001) and 3 other predicates after a 209-day review. Its family tree reaches back 1 generation to 1983. 11 later devices descend from it.

Decided
May 13, 2003
Review
209 days
Class
Class II
Product code
MNW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K830292 (1983). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1994: 1 other ancestor2005: 2 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2013: 3 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant clearedK830292 · Bioelectrical Impedance Analyzer #101 · Rjl Systems, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants K830292 · Bioelectrical Impedance Analyzer #101 · Rjl Systems, Inc. · 19830
  1. Root · 1 generation backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
  2. This deviceK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
  3. Descendant · cites it directly · 10 of its ownK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
  4. Descendant · 2 generations on · 8 of its ownK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
  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 · 3 generations on · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 22007: 12008: 12010: 12011: 22013: 32014: 1
2005high 3 (2013) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all
  • K042528Inbody, Model 3.0Biospace Corporation Limited · 2005 · cites it directly10descendants
  • K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005 · 2 generations on8descendants
  • K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · 2 generations on6descendants
  • K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 3 generations on4descendants
  • K110689InbodyBiospace Corporation Limited · 2011 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200710
200810
201010
201120
201330
201410
FIG. 1 — Lineage of K023478, 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K002835Bodystat
Summary page 1
…ANALYZER Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices BodyStat QuadScan 4000, K002835, RJL Systems BIA-IO1A, K830292, Tanita Corporation of America Body Fat Analyzer Model TBF-105, K930599, and Oniron Healthca…
Bodystat, Ltd.2001—
*K830292Bioelectrical Impedance Analyzer #101
Summary page 1
…74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices BodyStat QuadScan 4000, K002835, RJL Systems BIA-IO1A, K830292, Tanita Corporation of America Body Fat Analyzer Model TBF-105, K930599, and Oniron Healthcare Body Fat Analyzer Model HBF-…
Rjl Systems, Inc.1983—
*K930599Body Fat Analyzer Model TBF-105
Summary page 1
…Equivalent legally marketed devices BodyStat QuadScan 4000, K002835, RJL Systems BIA-IO1A, K830292, Tanita Corporation of America Body Fat Analyzer Model TBF-105, K930599, and Oniron Healthcare Body Fat Analyzer Model HBF- 306, KO 1 1652. 3. Indications for Use (intended use) For Measurement Of:…
Tanita Corp. of America1994—
*K011652Body Fat Analyzer, Model HBF-306Omron Healthcare, Inc.2001—

Also cleared against K002835: 7 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K042528Inbody, Model 3.0Biospace Corporation Limited200510

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K042528 (Biospace Corporation Limited, 2005) has gone furthest, with 10 descendants of its own.
  • 7 other devices also cite its predicate K002835.

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?

For Measurement Of:

Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates,

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

Indications for use as stated in the FDA summary.

Also cleared against K002835

7 other devices cite the same predicate.

  • K082255Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring UnitBodystat, Ltd. · 2011
  • K082254Modification to Bodystat 1500MDD Body Composition Monitoring UnitBodystat, Ltd. · 2011
  • K073334Ohmniscan NGChristine Valmy, Inc. · 2008
  • K070999BC (Body Composition Software)Rjl Systems, Inc. · 2007
  • K050415Impedimed-Extracellular Fluid AnalysisImpedimed Pty, Ltd. · 2007
  • K053556Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006

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/K023478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023478: Inbody AP1 Body Composition Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023478

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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