# K021700: Animus Ezserter Infusion Set Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Jun 4, 2002 after 12 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- 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 Sil-Setter™ infusion Set Insertion System: named in the summary without a submission number

## Indications for use
The Animas ezSerterTM Infusion Set Inserter is intended to aid in the insertion of the Animas ezSetTM infusion sets. This device is intended for home use and is a prescription device.

Source page: https://510kreport.com/device/K021700
Methodology: https://510kreport.com/methodology