# K042129: F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock

- Pathway: 510(k) (Traditional)
- Applicant: Cedic S.R.L.
- Decided: Jan 27, 2005 after 174 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: 1 generation back to K843692 (1984). 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)
- K843692: Flu Ven I.V. Set 0153-C Perma-Set, Venusa, Ltd. (1984) Summary page 1.

## Indications for use
The Cedic srl Intravenous Gravity Set is used for IVfluid administration. This device serves as a connection between the IVfluid container and an indwelling catheter.

Source page: https://510kreport.com/device/K042129
Methodology: https://510kreport.com/methodology