# K980583: Extension Set with 0.2U Filter and Anti-Siphon Valve Cadd Administration Set with 0.2U Filter and Anti-Siphon Valve

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Apr 27, 1998 after 69 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Extension Set with Anti-Siphon Valve: named in the summary without a submission number
- (no number) CADD® Administration Set with 0.2y Filter and Anti-Siphon Valve: named in the summary without a submission number
- (no number) Filter Set with 0.22p Filter, y-Injection Site and OPTION-LOK®: named in the summary without a submission number

## Indications for use
The CADD® Administration Set with 0.2y filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

Source page: https://510kreport.com/device/K980583
Methodology: https://510kreport.com/methodology