Injex 30 Needle Free Injection System, Model 100000
by Equidyne Systems, Inc. 510(k)
Active
510(k) K022502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022502 | Date5 Sep 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5430
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Injex 30 Needle Free Injection System, Model 100000, is a non-electrically powered fluid injector. It is designed for the subcutaneous injection of U-100 insulin, allowing for the administration of 5 to 30 insulin units in 1 unit increments.
This device is regulated under FDA 510(k) number K022502. It is classified under regulation number 880.5430 for use in a general hospital setting.
Other devices from Equidyne Systems, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Injex 30 Model 100000?
The Injex 30 is a non-electrically powered fluid injector specifically designed for the subcutaneous injection of U-100 insulin.
What dosage range can this injection system accommodate?
This device allows for the administration of insulin in doses ranging from 5 to 30 units, with the capability to adjust the dosage in 1 unit increments.
What is the regulatory status of this device?
The Injex 30 Needle Free Injection System, Model 100000, is regulated under FDA 510(k) number K022502 and is classified under regulation number 880.5430 for use in a general hospital setting.