Injector, Fluid, Non-Electrically Powered
FDA product code KZE · Class II (moderate risk) · 21 CFR 880.5430 · General Hospital
53510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Bioject, Inc. 7
- Derata Corp. 6
- Equidyne Systems, Inc. 5
- Medi-Ject Corp. 3
- Pharmajet, Inc. 3
- Vitajet Industriae Comercioltda. 2
- Biovalve Technologies, Inc. 2
- Felton International, Inc. 2
- National Medical Products, Inc. 2
- Vitajet Corp. 2
- California Medical Innovations, Inc. 1
- Sound 2000 Medical Systems, Inc. 1
- Med-E-Jet D 1
- Synergetics Inc 1
- International Medical Products, Inc. 1
- Injet Medical Products, Inc. 1
- Autoject Systems, Inc. 1
- Mada Medical Products, Inc. 1
- Uci Corp. 1
- Bioject Medical Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121270 | Bioject Needle-Free Injection Management SystemKZE · Traditional | Bioject Medical Technologies, Inc. | 07/19/2012SE |
| K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special | Pharmajet, Inc. | 07/27/2011SE |
| K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 03/02/2011SE |
| K090959 | Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional | D'Antonio Consultants International, Inc. (Dci) | 12/24/2009SE |
| K090003 | ZetajetKZE · Abbreviated | Bioject, Inc. | 04/02/2009SE |
| K081532 | Pharmajet Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 02/26/2009SE |
| K082138 | Airgent, Model AG7000010KZE · Traditional | Perfaction, Inc. | 01/23/2009SE |
| K060819 | Cool.Click 2KZE · Traditional | Medical House Products Limited | 06/16/2006SE |
| K051985 | Biovalve Mini-Ject Needlefree InjectorKZE · Special | Biovalve Technologies, Inc. | 08/17/2005SE |
| K050734 | Cool.ClickKZE · Traditional | Bioject, Inc. | 06/03/2005SE |
| K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000KZE · Traditional | Genesis Medical Technology, Inc. | 11/08/2004SE |
| K041280 | Human Subcutaneous Injector, Model Hsi 500KZE · Special | Felton International, Inc. | 06/24/2004SE |
| K032976 | Biovalve Miniject Needle-Free Injection System, Model FG-01-001KZE · Traditional | Biovalve Technologies, Inc. | 04/16/2004SE |
| K024018 | Avant Guardian 101KZE · Traditional | Avant Medical Corporation | 01/17/2003SE |
| K020786 | Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemKZE · Traditional | Rosch AG Medizintechnic | 09/25/2002SE |
| K022502 | Injex 30 Needle Free Injection System, Model 100000KZE · Traditional | Equidyne Systems, Inc. | 09/05/2002SE |
| K022148 | Injex 30 Needle Free Injection SystemKZE · Special | Equidyne Systems, Inc. | 07/23/2002SE |
| K013256 | BI-3M Needle-Free Injector SystemKZE · Traditional | Felton International, Inc. | 12/07/2001SE |
| K003741 | Jet Syringe MODEL-100500KZE · Traditional | Equidyne Systems, Inc. | 06/01/2001SE |
| K003908 | SerojetKZE · Traditional | Bioject, Inc. | 03/08/2001SE |
| K003864 | Injex 50 SystemKZE · Traditional | Equidyne Systems, Inc. | 03/06/2001SE |
| K994384 | ClickerKZE · Traditional | Bioject, Inc. | 06/22/2000SE |
| K991294 | Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery…KZE · Special | Medi-Ject Corp. | 04/23/1999SE |
| K980082 | J-Tip Needless InjectorKZE · Traditional | National Medical Products, Inc. | 03/04/1998SE |
| K973254 | J-Tip InjectorKZE · Traditional | National Medical Products, Inc. | 11/24/1997SE |
| K960373 | Biojector 2000 Model 1B02000KZE · Traditional | Bioject, Inc. | 03/05/1997SE |
| K962625 | VitajetKZE · Traditional | Vitajet Corp. | 12/10/1996SE |
| K962956 | Medi-Jector Choice Needle-Free Insulin Delivery SystemKZE · Traditional | Medi-Ject Corp. | 10/07/1996SE |
| K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems…KZE · Traditional | Medi-Ject Corp. | 04/17/1996SE |
| K945548 | MedivaxKZE · Traditional | Vitajet Corp. | 11/20/1995SE |
| K945873 | Hypex(Tm) Jet InjectorKZE · Traditional | Equidyne Systems, Inc. | 08/18/1995SE |
| K920631 | Bioject Jet Injection SystemKZE · Traditional | Bioject, Inc. | 06/28/1994SE |
| K921797 | Preci-Jet 50KZE · Traditional | Hmi Industries, Inc. | 11/17/1992SE |
| K923326 | Ophthalmic Viscoinjector DriveKZE · Traditional | Synergetics, Inc. | 09/30/1992SE |
| K913018 | Med-E-Jet InjectorKZE · Traditional | Med-E-Jet D | 09/16/1991SE |
| K905062 | Injector, InsulinKZE · Traditional | Sound 2000 Medical Systems, Inc. | 03/15/1991SE |
| K893215 | Vitajet(Insulin Jet Injection Device)KZE · Traditional | Vitajet Industriae Comercioltda. | 05/07/1990SE |
| K884293 | J-Tip Injector SystemKZE · Traditional | California Medical Innovations, Inc. | 01/09/1989SE |
| K883847 | Derata Medi-Jector VKZE · Traditional | Derata Corp. | 10/31/1988SE |
| K864984 | RobinjectKZE · Traditional | International Medical Products, Inc. | 06/29/1987SE |
| K861687 | Biojector Syringe SystemKZE · Traditional | Bioject, Inc. | 04/23/1987SE |
| K864561 | Derata Medi-Jector IVKZE · Traditional | Derata Corp. | 02/19/1987SE |
| K861582 | INJET-100, Fluid InjectorKZE · Traditional | Injet Medical Products, Inc. | 02/03/1987SE |
| K853031 | Ject-AidKZE · Traditional | Autoject Systems, Inc. | 01/01/1986SE |
| K850754 | Medajet XL - Jet InjectorKZE · Traditional | Mada Medical Products, Inc. | 12/10/1985SE |
| K844244 | Derata Medi-Jector ProKZE · Traditional | Derata Corp. | 07/05/1985SE |
| K851809 | Vacuum Compression InjectorKZE · Traditional | Uci Corp. | 07/01/1985SE |
| K851181 | Preci-Jet 50KZE · Traditional | Ulster Scientific, Inc. | 06/06/1985SE |
| K851029 | New VitajetKZE · Traditional | Andrew V. Stadler | 05/23/1985SE |
| K844111 | Derata Medi-Jector IIIKZE · Traditional | Derata Corp. | 11/28/1984SE |
| K843784 | Vitajet Jet Insulin Injection DeviceKZE · Traditional | Vitajet Industriae Comercioltda. | 11/02/1984SE |
| K834044 | Medi-Jector IIKZE · Traditional | Derata Corp. | 03/06/1984SE |
| K772129 | Medi-JectorKZE · Traditional | Derata Corp. | 12/08/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1541-2012 | Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT…Labeling clarification and software updates to include fixes for end of run summaries, increasing boot… | CaridianBCT, Inc. | 06/01/2010Terminated |