Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5430](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5430) → KZE — Injector, Fluid, Non-Electrically Powered # KZE · Injector, Fluid, Non-Electrically Powered _General Hospital · 21 CFR 880.5430 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE ## Overview - **Product Code:** KZE - **Device Name:** Injector, Fluid, Non-Electrically Powered - **Regulation:** [21 CFR 880.5430](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5430) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K121270.md) | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | Bioject Medical Technologies, Inc. | Jul 19, 2012 | SESE | | [K111517](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K111517.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K110456.md) | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | Mar 2, 2011 | SESE | | [K090959](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K090959.md) | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | Dec 24, 2009 | SESE | | [K090003](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K090003.md) | ZETAJET | Bioject, Inc. | Apr 2, 2009 | SESE | | [K081532](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K081532.md) | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | Feb 26, 2009 | SESE | | [K082138](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K082138.md) | AIRGENT, MODEL AG7000010 | Perfaction, Inc. | Jan 23, 2009 | SESE | | [K060819](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K060819.md) | COOL.CLICK 2 | Medical House Products Limited | Jun 16, 2006 | SESE | | [K051985](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K051985.md) | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | Biovalve Technologies, Inc. | Aug 17, 2005 | SESE | | [K050734](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K050734.md) | COOL.CLICK | Bioject, Inc. | Jun 3, 2005 | SESE | | [K041239](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K041239.md) | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | Genesis Medical Technology, Inc. | Nov 8, 2004 | SESE | | [K041280](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K041280.md) | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | Felton International, Inc. | Jun 24, 2004 | SESE | | [K032976](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K032976.md) | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | Biovalve Technologies, Inc. | Apr 16, 2004 | SESE | | [K024018](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K024018.md) | AVANT GUARDIAN 101 | Avant Medical Corporation | Jan 17, 2003 | SESE | | [K020786](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K020786.md) | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | Rosch AG Medizintechnic | Sep 25, 2002 | SESE | | [K022502](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K022502.md) | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | Equidyne Systems, Inc. | Sep 5, 2002 | SESE | | [K022148](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K022148.md) | INJEX 30 NEEDLE FREE INJECTION SYSTEM | Equidyne Systems, Inc. | Jul 23, 2002 | SESE | | [K013256](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K013256.md) | BI-3M NEEDLE-FREE INJECTOR SYSTEM | Felton International, Inc. | Dec 7, 2001 | SESE | | [K003741](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K003741.md) | JET SYRINGE MODEL-100500 | Equidyne Systems, Inc. | Jun 1, 2001 | SESE | | [K003908](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K003908.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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