# K062043: Body Composition Monitor with Scale, Model HBF-500

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 7, 2006 after 111 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K141483: Biospace Body Composition Analyzer (2014), 0 descendants of its own

## Indications for use
The Omron HBF-500 body composition monitor with scale is intended to be used to calculate and display the estimated value of body fat percentage, skeletal muscle percentage, resting metabolism, BMI and visceral fat levels using the BI (Bioelectrical Impedance) Method and indicates the BMI (Body Mass Index). The Omron HBF-500 is intended to be used by healthy individuals in the age range of 18 to 80 years for the skeletal muscle percentage, resting metabolism and visceral fat level. The age range for body fat percentage is intended to be used by healthy individuals between the age of 10 to 80 years.

Source page: https://510kreport.com/device/K062043
Methodology: https://510kreport.com/methodology