510(k) · Cleared
ClearedInbody, Model 3.0
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 Jan 11, 2005 as substantially equivalent to K002835 (Bodystat, Ltd., 2001) and 2 other predicates after a 116-day review. Its family tree reaches back 2 generations to 1983. 10 later devices descend from it.
- Decided
- Jan 11, 2005
- Review
- 116 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830292 (1983). 5 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 1 generation backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- This deviceK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- Descendant · cites it directly · 8 of its ownK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- Descendant · cites it directly · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- Descendant · 2 generations on · 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005 · cites it directly8descendants
- K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · cites it directly6descendants
- K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 2 generations on4descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −1 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K002835 | BodystatSummary page 1…dy API BODY COMPOSITION ANALYZER Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: K002835 BodyStat QuadScan 4000; K830292 RJL Systems BIA-l0LA; K023478 Biospace Body Composition Analyzer Model InBody API 3. Indic… | 2001 |
| * | K830292 | Bioelectrical Impedance Analyzer #101Summary page 1…Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: K002835 BodyStat QuadScan 4000; K830292 RJL Systems BIA-l0LA; K023478 Biospace Body Composition Analyzer Model InBody API 3. Indications for Use (intended use) Fo… | 1983 |
| * | K023478 | Inbody AP1 Body Composition AnalyzerSummary page 1…ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter 2. Equivalent legally marketed devices: K002835 BodyStat QuadScan 4000; K830292 RJL Systems BIA-l0LA; K023478 Biospace Body Composition Analyzer Model InBody API 3. Indications for Use (intended use) For use only in healthy subjects fo… | 2003 |
What descends from it? (10)
3 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 22 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K052646 (Biospace Corporation Limited, 2005) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K002835.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.
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: Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water (TBW), ECW to TBW ratio, 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/K042528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042528: Inbody, Model 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042528
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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