# K023817: Smartshape Body Composition Analyzer, Model 4010

- Pathway: 510(k) (Traditional)
- Applicant: Clio Designs, Inc.
- Decided: Jun 25, 2003 after 222 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: 1 generation back to K011652 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011652: Body Fat Analyzer, Model HBF-306, Omron Healthcare, Inc. (2001)

## Indications for use
The Smartshape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.

Source page: https://510kreport.com/device/K023817
Methodology: https://510kreport.com/methodology