# K994429: Venusa, LTD. Extension Set with Filter

- Pathway: 510(k) (Traditional)
- Applicant: Venusa, Ltd.
- Decided: Mar 3, 2000 after 64 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960466 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960466: Ivex-2 Extension Set with Y-Injection Site (Modification), Abbott Laboratories (1996) Summary page 1.
- K964850: Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter, Baxter Healthcare Corp (1997) Summary page 1.

## Indications for use
The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where removal of particulate greater than 0.22 micron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.

Source page: https://510kreport.com/device/K994429
Methodology: https://510kreport.com/methodology