# K972383: Easy-Jet Device

- Pathway: 510(k) (Traditional)
- Applicant: A.Stein - Regulatory Affairs Consulting
- Decided: Nov 23, 1999 after 880 days
- Product code: KLZ (Tube, Shunt, Endolymphatic With Valve)
- Device class: 2
- Regulation: 21 CFR 874.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051667: EZ-Ject (2005), 0 descendants of its own

## Indications for use
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and ncedle withdrawal.

Source page: https://510kreport.com/device/K972383
Methodology: https://510kreport.com/methodology