# K904109: Bio-Impedance Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Xitron Technologies, Inc.
- Decided: Jan 8, 1991 after 124 days
- Product code: DSB (Plethysmograph, Impedance)
- 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.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052319: Impedimed - Body Composition Analyzer, Model Imp SFB7 (2006), 13 descendants of its own
- K050415: Impedimed-Extracellular Fluid Analysis (2007), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K904109
Methodology: https://510kreport.com/methodology