Product Code: KZE FDA class 2 21 CFR 880.5430

Injector, Fluid, Non-Electrically Powered

General Hospital

The Non-Electrically Powered Fluid Injector is a mechanical device that uses manual or pneumatic force to inject fluids into patients without reliance on an electrical power source, used in settings where controlled fluid delivery is needed without powered equipment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZE, regulated under 21 CFR 880.5430, in the General Hospital medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: KZE
Device Class: FDA class 2
Regulation Number: 880.5430
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K121270	BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM	Jul 19, 2012	Substantially Equivalent	Bioject Medical Technologies, Inc.
K111517	PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI	Jul 27, 2011	Substantially Equivalent	Pharmajet, Inc.
K110456	PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM	Mar 02, 2011	Substantially Equivalent	Pharmajet, Inc.
K090959	LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA	Dec 24, 2009	Substantially Equivalent	D'Antonio Consultants International, Inc. (Dci)
K090003	ZETAJET	Apr 02, 2009	Substantially Equivalent	Bioject, Inc.
K081532	PHARMAJET NEEDLE-FREE INJECTION SYSTEM	Feb 26, 2009	Substantially Equivalent	Pharmajet, Inc.
K082138	AIRGENT, MODEL AG7000010	Jan 23, 2009	Substantially Equivalent	Perfaction, Inc.
K060819	COOL.CLICK 2	Jun 16, 2006	Substantially Equivalent	Medical House Products Limited
K051985	BIOVALVE MINI-JECT NEEDLEFREE INJECTOR	Aug 17, 2005	Substantially Equivalent	Biovalve Technologies, Inc.
K050734	COOL.CLICK	Jun 03, 2005	Substantially Equivalent	Bioject, Inc.
K041239	GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000	Nov 08, 2004	Substantially Equivalent	Genesis Medical Technology, Inc.
K041280	HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500	Jun 24, 2004	Substantially Equivalent	Felton International, Inc.
K032976	BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001	Apr 16, 2004	Substantially Equivalent	Biovalve Technologies, Inc.
K024018	AVANT GUARDIAN 101	Jan 17, 2003	Substantially Equivalent	Avant Medical Corporation
K020786	INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM	Sep 25, 2002	Substantially Equivalent	Rosch AG Medizintechnic
K022502	INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000	Sep 05, 2002	Substantially Equivalent	Equidyne Systems, Inc.
K022148	INJEX 30 NEEDLE FREE INJECTION SYSTEM	Jul 23, 2002	Substantially Equivalent	Equidyne Systems, Inc.
K013256	BI-3M NEEDLE-FREE INJECTOR SYSTEM	Dec 07, 2001	Substantially Equivalent	Felton International, Inc.
K003741	JET SYRINGE MODEL-100500	Jun 01, 2001	Substantially Equivalent	Equidyne Systems, Inc.
K003908	SEROJET	Mar 08, 2001	Substantially Equivalent	Bioject, Inc.
K003864	INJEX 50 SYSTEM	Mar 06, 2001	Substantially Equivalent	Equidyne Systems, Inc.
K994384	CLICKER	Jun 22, 2000	Substantially Equivalent	Bioject, Inc.
K991294	MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM	Apr 23, 1999	Substantially Equivalent	Medi-Ject Corp.
K980082	J-TIP NEEDLESS INJECTOR	Mar 04, 1998	Substantially Equivalent	National Medical Products, Inc.
K973254	J-TIP INJECTOR	Nov 24, 1997	Substantially Equivalent	National Medical Products, Inc.
K960373	BIOJECTOR 2000 MODEL 1B02000	Mar 05, 1997	Substantially Equivalent	Bioject, Inc.
K962625	VITAJET	Dec 10, 1996	Substantially Equivalent	Vitajet Corp.
K962956	MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM	Oct 07, 1996	Substantially Equivalent	Medi-Ject Corp.
K960285	MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC	Apr 17, 1996	Substantially Equivalent	Medi-Ject Corp.
K945548	MEDIVAX	Nov 20, 1995	Substantially Equivalent	Vitajet Corp.
K945873	HYPEX(TM) JET INJECTOR	Aug 18, 1995	Substantially Equivalent	Equidyne Systems, Inc.
K920631	BIOJECT JET INJECTION SYSTEM	Jun 28, 1994	Substantially Equivalent	Bioject, Inc.
K921797	PRECI-JET 50	Nov 17, 1992	Substantially Equivalent	Hmi Industries, Inc.
K923326	OPHTHALMIC VISCOINJECTOR DRIVE	Sep 30, 1992	Substantially Equivalent	Synergetics, Inc.
K913018	MED-E-JET INJECTOR	Sep 16, 1991	Substantially Equivalent	Med-E-Jet D
K905062	INJECTOR, INSULIN	Mar 15, 1991	Substantially Equivalent	Sound 2000 Medical Systems, Inc.
K893215	VITAJET(INSULIN JET INJECTION DEVICE)	May 07, 1990	Substantially Equivalent	Vitajet Industriae Comercioltda.
K884293	J-TIP INJECTOR SYSTEM	Jan 09, 1989	Substantially Equivalent	California Medical Innovations, Inc.
K883847	DERATA MEDI-JECTOR V	Oct 31, 1988	Substantially Equivalent	Derata Corp.
K864984	ROBINJECT	Jun 29, 1987	Substantially Equivalent	International Medical Products, Inc.
K861687	BIOJECTOR SYRINGE SYSTEM	Apr 23, 1987	Substantially Equivalent	Bioject, Inc.
K864561	DERATA MEDI-JECTOR IV	Feb 19, 1987	Substantially Equivalent	Derata Corp.
K861582	INJET-100, FLUID INJECTOR	Feb 03, 1987	Substantially Equivalent	Injet Medical Products, Inc.
K853031	JECT-AID	Jan 01, 1986	Substantially Equivalent	Autoject Systems, Inc.
K850754	MEDAJET XL - JET INJECTOR	Dec 10, 1985	Substantially Equivalent	Mada Medical Products, Inc.
K844244	DERATA MEDI-JECTOR PRO	Jul 05, 1985	Substantially Equivalent	Derata Corp.
K851809	VACUUM COMPRESSION INJECTOR	Jul 01, 1985	Substantially Equivalent	Uci Corp.
K851181	PRECI-JET 50	Jun 06, 1985	Substantially Equivalent	Ulster Scientific, Inc.
K851029	NEW VITAJET	May 23, 1985	Substantially Equivalent	Andrew V. Stadler
K844111	DERATA MEDI-JECTOR III	Nov 28, 1984	Substantially Equivalent	Derata Corp.
K843784	VITAJET JET INSULIN INJECTION DEVICE	Nov 02, 1984	Substantially Equivalent	Vitajet Industriae Comercioltda.
K834044	MEDI-JECTOR II	Mar 06, 1984	Substantially Equivalent	Derata Corp.
K772129	MEDI-JECTOR	Dec 08, 1977	Substantially Equivalent	Derata Corp.