# K080650: Omni-DL System

- Pathway: 510(k) (Traditional)
- Applicant: Transvivo, Inc.
- Decided: Nov 26, 2008 after 264 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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 K946279 (1997). 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)
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.

## Indications for use
The Omni System, which consists of the Omni-DLTM Control Unit, Omni-DL TM CWHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting where CRRT is administered. Four different solute and fluid management therapies are available: SCUF (Slow Continuous Ultrafiltration) CVVH (Continuous Veno-venous Hemofiltration) CVVHD (Continuous Veno-venous Hemodialysis) CVVHDF (Continuous Veno-venous Hemodiafiltration)

Source page: https://510kreport.com/device/K080650
Methodology: https://510kreport.com/methodology