# K042528: Inbody, Model 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Corporation Limited
- Decided: Jan 11, 2005 after 116 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: 2 generations back to K830292 (1983). 5 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 1.
- K830292: Bioelectrical Impedance Analyzer #101, Rjl Systems, Inc. (1983) Summary page 1.
- K023478: Inbody AP1 Body Composition Analyzer, Biospace Co.,Ltd (2003) Summary page 1.

## Most influential descendants
- K052646: Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 (2005), 8 descendants of its own
- K062603: Biospace Body Composition Analyzers, Model Inbody 230 (2007), 6 descendants of its own
- K092786: Inbody, Models: 270, R20, R20B (2010), 4 descendants of its own
- K110689: Inbody (2011), 3 descendants of its own
- K123228: Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) (2013), 2 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K042528
Methodology: https://510kreport.com/methodology