# K081587: Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530

- Pathway: 510(k) (Traditional)
- Applicant: Krell Precision (Yang Zhou) Co., Ltd.
- Decided: Oct 24, 2008 after 141 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: 3 generations back to K930599 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040778: Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9), Tanita Corp. of America (2004) Summary page 1.
- K030349: Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960, Bonso Electronics International, Inc. (2003) Summary page 3.

## Indications for use
The KRELL Weight & Body Fat Monitoring Scale is indicated to measure body weight and impedance and estimate the percentage of Body Fat and body water, Bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults and children (from age 10 and up) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.

Source page: https://510kreport.com/device/K081587
Methodology: https://510kreport.com/methodology