# K041495: Pentadeflue IV Solution Administration Sets

- Pathway: 510(k) (Abbreviated)
- Applicant: Pentaferte S.P.A
- Decided: Apr 15, 2005 after 315 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 K921860 (1992). 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)
- K023469: Victus I.V. Administration Set, Models 27058, 27059,27062, Victus, Inc. (2002) Summary page 1.

## Indications for use
To administer IVFluids into a patient's vascular system

Source page: https://510kreport.com/device/K041495
Methodology: https://510kreport.com/methodology