# K012754: EZ Set Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Aug 27, 2001 after 11 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) MiniMed Paradigm Silhouette Infusion Set: named in the summary without a submission number
- (no number) Maersk Medical Comfort Infusion Set: named in the summary without a submission number
- (no number) Disetronic Tender Infusion Set: named in the summary without a submission number

## Indications for use
The Animas EZ Set Infusion set is intended to provide subcutaneous infusion of medicine, including insulin, from an external infusion pump. This device is intended for home use and is a prescription device.

Source page: https://510kreport.com/device/K012754
Methodology: https://510kreport.com/methodology