# K052319: Impedimed - Body Composition Analyzer, Model Imp SFB7

- Pathway: 510(k) (Traditional)
- Applicant: Impedimed Pty, Ltd.
- Decided: Apr 4, 2006 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 K904109 (1991). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904109: Bio-Impedance Analyzer, Xitron Technologies, Inc. (1991) Summary page 2.

## Most influential descendants
- K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 (2008), 10 descendants of its own
- K100811: Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 (2011), 7 descendants of its own
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis (2013), 6 descendants of its own
- K171186: Cerebrotech CMS-5000 (2017), 2 descendants of its own
- K172122: SOZO (2017), 2 descendants of its own

## Indications for use
(1) Imp SFB7 - A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, weight, age and sex. (2) BioImp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above. These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.

Source page: https://510kreport.com/device/K052319
Methodology: https://510kreport.com/methodology