# K011652: Body Fat Analyzer, Model HBF-306

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 7, 2001 after 162 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
No predicates in its family tree.
23 later devices descend from it; 12 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023478: Inbody AP1 Body Composition Analyzer (2003), 11 descendants of its own
- K042528: Inbody, Model 3.0 (2005), 10 descendants of its own
- 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

## Indications for use
The device Is noninvasive bioimpedance analyzer for use in estimating human's body fat volume (mass) and percentage by weight. The applicable age range is 10 to 80 years for normal subjects and 18 to 60 years for athletic subjects.

Source page: https://510kreport.com/device/K011652
Methodology: https://510kreport.com/methodology