# K051667: EZ-Ject

- Pathway: 510(k) (Traditional)
- Applicant: Indolor, Ltd.
- Decided: Sep 27, 2005 after 97 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
Longest line of descent: 1 generation back to K972383 (1999). 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)
- K972383: Easy-Jet Device, A.Stein - Regulatory Affairs Consulting (1999) Summary page 1.

## Indications for use
The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.

Source page: https://510kreport.com/device/K051667
Methodology: https://510kreport.com/methodology