510(k) · Cleared
ClearedBiospace Body Composition Analyzer
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 Sep 23, 2014 as substantially equivalent to K110689 (Biospace Corporation Limited, 2011) and 1 other predicate after a 110-day review. Its family tree reaches back 8 generations to 1983.
- Decided
- Sep 23, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K830292 (1983). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 7 generations backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- 6 generations backK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- 5 generations backK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- 4 generations backK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- 3 generations backK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
- 2 generations backK110689 InbodyBiospace Corporation Limited · 2011
- 1 generation backK123228 Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013
- This deviceK141483 Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −7 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| −6 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| −5 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
| −4 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| −3 | K092786 | Inbody, Models: 270, R20, R20B | Biospace Corporation Limited | 2010 | — |
| −2 | K110689 | Inbody | Biospace Corporation Limited | 2011 | — |
| −1 | K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) | Biospace Corporation Limited | 2013 | — |
| 0 (this device) | K141483 | Biospace Body Composition Analyzer | Biospace Corporation Limited | 2014 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K110689 | InbodySummary page 4…2770 Classification: I Equivalent legally marketed devices: (Predicate device Information) Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody570, InBodyS10, InBody H20. Indications for Use:… | 2011 |
| * | K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Summary page 4…s: (Predicate device Information) Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody570, InBodyS10, InBody H20. Indications for Use: For use only in healthy subjects for Measurement of: Estim… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 16 ancestors has a recall.
- 2 other devices also cite its predicate K110689.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water…
Read the full statement (129 words)
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), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ECW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141483: Biospace 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/K141483
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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