KZE · Injector, Fluid, Non-Electrically Powered
General Hospital · 21 CFR 880.5430 · Class 2
Overview
| Product Code | KZE |
|---|---|
| Device Name | Injector, Fluid, Non-Electrically Powered |
| Regulation | 21 CFR 880.5430 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121270 | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | Bioject Medical Technologies, Inc. | Jul 19, 2012 | SESE |
| K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | Pharmajet, Inc. | Jul 27, 2011 | SESE |
| K110456 | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | Mar 2, 2011 | SESE |
| K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | Dec 24, 2009 | SESE |
| K090003 | ZETAJET | Bioject, Inc. | Apr 2, 2009 | SESE |
| K081532 | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | Feb 26, 2009 | SESE |
| K082138 | AIRGENT, MODEL AG7000010 | Perfaction, Inc. | Jan 23, 2009 | SESE |
| K060819 | COOL.CLICK 2 | Medical House Products Limited | Jun 16, 2006 | SESE |
| K051985 | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | Biovalve Technologies, Inc. | Aug 17, 2005 | SESE |
| K050734 | COOL.CLICK | Bioject, Inc. | Jun 3, 2005 | SESE |
| K041239 | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | Genesis Medical Technology, Inc. | Nov 8, 2004 | SESE |
| K041280 | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | Felton International, Inc. | Jun 24, 2004 | SESE |
| K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | Biovalve Technologies, Inc. | Apr 16, 2004 | SESE |
| K024018 | AVANT GUARDIAN 101 | Avant Medical Corporation | Jan 17, 2003 | SESE |
| K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | Rosch AG Medizintechnic | Sep 25, 2002 | SESE |
| K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | Equidyne Systems, Inc. | Sep 5, 2002 | SESE |
| K022148 | INJEX 30 NEEDLE FREE INJECTION SYSTEM | Equidyne Systems, Inc. | Jul 23, 2002 | SESE |
| K013256 | BI-3M NEEDLE-FREE INJECTOR SYSTEM | Felton International, Inc. | Dec 7, 2001 | SESE |
| K003741 | JET SYRINGE MODEL-100500 | Equidyne Systems, Inc. | Jun 1, 2001 | SESE |
| K003908 | SEROJET | Bioject, Inc. | Mar 8, 2001 | SESE |
Top Applicants
- Bioject, Inc. — 7 clearances
- Derata Corp. — 6 clearances
- Equidyne Systems, Inc. — 5 clearances
- Medi-Ject Corp. — 3 clearances
- Pharmajet, Inc. — 3 clearances
