Product code KZE
- Device name
- Injector, Fluid, Non-Electrically Powered
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5430
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121270 | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | Bioject Medical Technologies, Inc. | 2012-07-19 |
| K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | Pharmajet, Inc. | 2011-07-27 |
| K110456 | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2011-03-02 |
| K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | 2009-12-24 |
| K090003 | ZETAJET | Bioject, Inc. | 2009-04-02 |
| K081532 | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2009-02-26 |
| K082138 | AIRGENT, MODEL AG7000010 | Perfaction, Inc. | 2009-01-23 |
| K060819 | COOL.CLICK 2 | Medical House Products Limited | 2006-06-16 |
| K051985 | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | Biovalve Technologies, Inc. | 2005-08-17 |
| K050734 | COOL.CLICK | Bioject, Inc. | 2005-06-03 |
| K041239 | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | Genesis Medical Technology, Inc. | 2004-11-08 |
| K041280 | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | Felton International, Inc. | 2004-06-24 |
| K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | Biovalve Technologies, Inc. | 2004-04-16 |
| K024018 | AVANT GUARDIAN 101 | Avant Medical Corporation | 2003-01-17 |
| K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | Rosch AG Medizintechnic | 2002-09-25 |
| K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | Equidyne Systems, Inc. | 2002-09-05 |
| K022148 | INJEX 30 NEEDLE FREE INJECTION SYSTEM | Equidyne Systems, Inc. | 2002-07-23 |
| K013256 | BI-3M NEEDLE-FREE INJECTOR SYSTEM | Felton International, Inc. | 2001-12-07 |
| K003741 | JET SYRINGE MODEL-100500 | Equidyne Systems, Inc. | 2001-06-01 |
| K003908 | SEROJET | Bioject, Inc. | 2001-03-08 |
| K003864 | INJEX 50 SYSTEM | Equidyne Systems, Inc. | 2001-03-06 |
| K994384 | CLICKER | Bioject, Inc. | 2000-06-22 |
| K991294 | MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM | Medi-Ject Corp. | 1999-04-23 |
| K980082 | J-TIP NEEDLESS INJECTOR | National Medical Products, Inc. | 1998-03-04 |
| K973254 | J-TIP INJECTOR | National Medical Products, Inc. | 1997-11-24 |
| K960373 | BIOJECTOR 2000 MODEL 1B02000 | Bioject, Inc. | 1997-03-05 |
| K962625 | VITAJET | Vitajet Corp. | 1996-12-10 |
| K962956 | MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM | Medi-Ject Corp. | 1996-10-07 |
| K960285 | MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC | Medi-Ject Corp. | 1996-04-17 |
| K945548 | MEDIVAX | Vitajet Corp. | 1995-11-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199284222250 | Robbins Dermo-jet | Robbins Instruments Inc. | 2025-08-22 |
| 07290016746754 | Treatment Kit 2.0 | VIORA LTD | 2025-06-03 |
| 07290016746761 | Treatment Kit 2.0 | VIORA LTD | 2025-06-03 |
| 07290016746716 | Console | VIORA LTD | 2025-05-22 |
| 07290016746723 | Applicator | VIORA LTD | 2025-05-22 |
| 07290016746730 | Trolley | VIORA LTD | 2025-05-22 |
| 07290016746747 | Disposable Delivery Nozzle | VIORA LTD | 2025-05-22 |
| B07281641001 | J-Tip | NATIONAL MEDICAL PRODUCTS, INC. | 2024-05-27 |
| B07281642001 | J-Tip | NATIONAL MEDICAL PRODUCTS, INC. | 2024-05-27 |
| 07290017151007 | AirGent-2.0 | PERFACTION TECHNOLOGIES LTD | 2018-12-18 |
| 07640180261018 | ZOMA-Jet | FERRING PHARMACEUTICALS INC. | 2018-08-01 |
| 07640180261001 | ZOMA-Jet | FERRING PHARMACEUTICALS INC. | 2018-08-01 |
| 00856457003374 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003367 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003312 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003305 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003213 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003206 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003336 | Stratis® | PHARMAJET, INC. | 2016-09-19 |
| 00856457003329 | Stratis® | PHARMAJET, INC. | 2016-09-19 |