# K042172: Cleo 90 Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Oct 7, 2004 after 57 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) Unomedical Comfort Set: named in the summary without a submission number
- (no number) Disetronic Ultraflex Set: named in the summary without a submission number
- (no number) Medtronic MiniMed Sof-Set: named in the summary without a submission number

## Indications for use
The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for intravenous (IV) infusion or to infuse blood or blood products

Source page: https://510kreport.com/device/K042172
Methodology: https://510kreport.com/methodology