510(k) · Cleared
ClearedBiospace Body Composition Analyzers, Model Inbody 230
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biospace Corporation Limited · MNW Analyzer, Body Composition
Cleared on Feb 15, 2007 as substantially equivalent to K042528 (Biospace Corporation Limited, 2005) and 3 other predicates after a 167-day review. Its family tree reaches back 4 generations to 1983. 6 later devices descend from it.
- Decided
- Feb 15, 2007
- Review
- 167 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K830292 (1983). 12 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 3 generations backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- 2 generations backK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- 1 generation backK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- This deviceK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- Descendant · cites it directly · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
- Descendant · 2 generations on · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011
- Descendant · 3 generations on · 2 of its ownK123228 Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013
- Descendant · 3 generations on · 0 of its ownK141483 Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
- Descendant · 3 generations on · 0 of its ownK130777 InbodyBiospace Corporation Limited · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · cites it directly4descendants
- K110689InbodyBiospace Corporation Limited · 2011 · 2 generations on3descendants
- K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013 · 3 generations on2descendants
- K141483Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014 · 3 generations on0descendants
- K130777InbodyBiospace Corporation Limited · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −3 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| −2 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| −1 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
| 0 (this device) | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| +1 | K092786 | Inbody, Models: 270, R20, R20B | Biospace Corporation Limited | 2010 | — |
| +2 | K110689 | Inbody | Biospace Corporation Limited | 2011 | — |
| +3 | K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) | Biospace Corporation Limited | 2013 | — |
| +3 | K141483 | Biospace Body Composition Analyzer | Biospace Corporation Limited | 2014 | — |
| +3 | K130777 | Inbody | Biospace Corporation Limited | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
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 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042528 | Inbody, Model 3.0Summary page 1…: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528, Model InBody 520, K052646. Predicates for skeletal muscle mass are: Tanita Ironman Innerscan Body Composition Monitor Model B… | 2005 |
| * | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Summary page 1…POSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: Biospace Body Composition Analyzer Model InBody 3.0, K042528, Model InBody 520, K052646. Predicates for skeletal muscle mass are: Tanita Ironman Innerscan Body Composition Monitor Model BC-558 (K062652 and Omron Bo… | 2005 |
| * | K062652 | Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor Cleared while this submission was under review Summary page 1…yzer Model InBody 3.0, K042528, Model InBody 520, K052646. Predicates for skeletal muscle mass are: Tanita Ironman Innerscan Body Composition Monitor Model BC-558 (K062652 and Omron Body Composition Monitor and Scale Model HBF-500 (K062043) 3. Indications for Use (intended use) For use only in he… | 2006 |
| * | K062043 | Body Composition Monitor with Scale, Model HBF-500 Cleared while this submission was under review Summary page 1…s for skeletal muscle mass are: Tanita Ironman Innerscan Body Composition Monitor Model BC-558 (K062652 and Omron Body Composition Monitor and Scale Model HBF-500 (K062043) 3. Indications for Use (intended use) For use only in healthy subjects for Measurement of: Estimated : Skeletal muscle mass,… | 2006 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K092786 (Biospace Corporation Limited, 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K042528.
How does its category compare?
All MNW devicesMNW 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MNW
110in 2014
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
MAUDE reports naming product code MNW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 109 | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 137 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 11 | 168 | 0 | 0 |
| 2012 | 4 | 103 | 0 | 0 |
| 2013 | 9 | 144 | 0 | 0 |
| 2014 | 3 | 110 | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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, (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass,
Actual : Weight, Body Mass Index (BMI),and Impedance Values
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062603: Biospace Body Composition Analyzers, Model Inbody 230.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062603
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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