# K962783: Edema System

- Pathway: 510(k) (Traditional)
- Applicant: Bioanalogics, Inc.
- Decided: Oct 23, 1997 after 463 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
Longest line of descent: 1 generation back to K871040 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871040: Consultant Body Composition Analyzer, Body Composition Analog, Inc. (1987) Summary page 1.

## Indications for use
The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating increased-extremity edema.

Source page: https://510kreport.com/device/K962783
Methodology: https://510kreport.com/methodology