Product code KZE— General Hospital
PRECI-JET 50
- Classification name
- Injector, Fluid, Non-Electrically Powered
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code KZE
FDA has cleared devices under product code KZE between 1977 and 2012, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2012
- 2011
- 2009
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
Top applicants under product code KZE
Recent clearances under product code KZE
- K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
- K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
- K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
- K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
- K090003 — ZETAJET
- K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM
- K082138 — AIRGENT, MODEL AG7000010
- K060819 — COOL.CLICK 2
- K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
- K050734 — COOL.CLICK
- K041239 — GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
- K041280 — HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
- K032976 — BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
- K024018 — AVANT GUARDIAN 101
- K020786 — INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
- K022502 — INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
- K022148 — INJEX 30 NEEDLE FREE INJECTION SYSTEM
- K013256 — BI-3M NEEDLE-FREE INJECTOR SYSTEM
- K003741 — JET SYRINGE MODEL-100500
- K003908 — SEROJET
- K003864 — INJEX 50 SYSTEM
- K994384 — CLICKER
- K991294 — MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
- K980082 — J-TIP NEEDLESS INJECTOR
- K973254 — J-TIP INJECTOR
- K960373 — BIOJECTOR 2000 MODEL 1B02000
- K962625 — VITAJET
- K962956 — MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
- K960285 — MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
- K945548 — MEDIVAX
- K945873 — HYPEX(TM) JET INJECTOR
- K920631 — BIOJECT JET INJECTION SYSTEM
- K921797 — PRECI-JET 50
- K923326 — OPHTHALMIC VISCOINJECTOR DRIVE
- K913018 — MED-E-JET INJECTOR
- K905062 — INJECTOR, INSULIN
- K893215 — VITAJET(INSULIN JET INJECTION DEVICE)
- K884293 — J-TIP INJECTOR SYSTEM
- K883847 — DERATA MEDI-JECTOR V
- K864984 — ROBINJECT
- K861687 — BIOJECTOR SYRINGE SYSTEM
- K864561 — DERATA MEDI-JECTOR IV
- K861582 — INJET-100, FLUID INJECTOR
- K853031 — JECT-AID
- K850754 — MEDAJET XL - JET INJECTOR
- K844244 — DERATA MEDI-JECTOR PRO
- K851809 — VACUUM COMPRESSION INJECTOR
- K851181 — PRECI-JET 50
- K851029 — NEW VITAJET
- K844111 — DERATA MEDI-JECTOR III
- K843784 — VITAJET JET INSULIN INJECTION DEVICE
- K834044 — MEDI-JECTOR II
- K772129 — MEDI-JECTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.