# K110689: Inbody

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Corporation Limited
- Decided: Aug 19, 2011 after 157 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K830292 (1983). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052646: Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20, Biospace Corporation Limited (2005) Summary page 1.
- K092786: Inbody, Models: 270, R20, R20B, Biospace Corporation Limited (2010) Summary page 1.
- (no number) BSM370 scale, stand-patient: named in the summary without a submission number

## Most influential descendants
- K123228: Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) (2013), 2 descendants of its own
- K141483: Biospace Body Composition Analyzer (2014), 0 descendants of its own
- K130777: Inbody (2013), 0 descendants of its own

## Indications for use
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, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (yEA). Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ3O, which has height-meter function]

Source page: https://510kreport.com/device/K110689
Methodology: https://510kreport.com/methodology