Atlas FDA

KZE

53 FDA 510(k) clearances · Product code

89 daysmedian time to decision
288 days90th percentile
53clearances measured

FDA profile

Official device name
Injector, Fluid, Non-Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5430
Medical specialty
General Hospital
Adverse events (MAUDE)
2008: 5 · 2009: 8 · 2010: 9 · 2011: 7 · 2012: 6 · 2014: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (K121270)Bioject Medical Technologies, Inc.2012-07-19
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI (K111517)Pharmajet, Inc.2011-07-27
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (K110456)Pharmajet, Inc.2011-03-02
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (K090959)D'Antonio Consultants International, Inc. (Dci)2009-12-24
ZETAJET (K090003)Bioject, Inc.2009-04-02
PHARMAJET NEEDLE-FREE INJECTION SYSTEM (K081532)Pharmajet, Inc.2009-02-26
AIRGENT, MODEL AG7000010 (K082138)Perfaction, Inc.2009-01-23
COOL.CLICK 2 (K060819)Medical House Products Limited2006-06-16
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (K051985)Biovalve Technologies, Inc.2005-08-17
COOL.CLICK (K050734)Bioject, Inc.2005-06-03
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (K041239)Genesis Medical Technology, Inc.2004-11-08
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 (K041280)Felton International, Inc.2004-06-24
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 (K032976)Biovalve Technologies, Inc.2004-04-16
AVANT GUARDIAN 101 (K024018)Avant Medical Corporation2003-01-17
INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM (K020786)Rosch AG Medizintechnic2002-09-25
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 (K022502)Equidyne Systems, Inc.2002-09-05
INJEX 30 NEEDLE FREE INJECTION SYSTEM (K022148)Equidyne Systems, Inc.2002-07-23
BI-3M NEEDLE-FREE INJECTOR SYSTEM (K013256)Felton International, Inc.2001-12-07
JET SYRINGE MODEL-100500 (K003741)Equidyne Systems, Inc.2001-06-01
SEROJET (K003908)Bioject, Inc.2001-03-08
INJEX 50 SYSTEM (K003864)Equidyne Systems, Inc.2001-03-06
CLICKER (K994384)Bioject, Inc.2000-06-22
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM (K991294)Medi-Ject Corp.1999-04-23
J-TIP NEEDLESS INJECTOR (K980082)National Medical Products, Inc.1998-03-04
J-TIP INJECTOR (K973254)National Medical Products, Inc.1997-11-24
BIOJECTOR 2000 MODEL 1B02000 (K960373)Bioject, Inc.1997-03-05
VITAJET (K962625)Vitajet Corp.1996-12-10
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM (K962956)Medi-Ject Corp.1996-10-07
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC (K960285)Medi-Ject Corp.1996-04-17
MEDIVAX (K945548)Vitajet Corp.1995-11-20
HYPEX(TM) JET INJECTOR (K945873)Equidyne Systems, Inc.1995-08-18
BIOJECT JET INJECTION SYSTEM (K920631)Bioject, Inc.1994-06-28
PRECI-JET 50 (K921797)Hmi Industries, Inc.1992-11-17
OPHTHALMIC VISCOINJECTOR DRIVE (K923326)Synergetics, Inc.1992-09-30
MED-E-JET INJECTOR (K913018)Med-E-Jet D1991-09-16
INJECTOR, INSULIN (K905062)Sound 2000 Medical Systems, Inc.1991-03-15
VITAJET(INSULIN JET INJECTION DEVICE) (K893215)Vitajet Industriae Comercioltda.1990-05-07
J-TIP INJECTOR SYSTEM (K884293)California Medical Innovations, Inc.1989-01-09
DERATA MEDI-JECTOR V (K883847)Derata Corp.1988-10-31
ROBINJECT (K864984)International Medical Products, Inc.1987-06-29
BIOJECTOR SYRINGE SYSTEM (K861687)Bioject, Inc.1987-04-23
DERATA MEDI-JECTOR IV (K864561)Derata Corp.1987-02-19
INJET-100, FLUID INJECTOR (K861582)Injet Medical Products, Inc.1987-02-03
JECT-AID (K853031)Autoject Systems, Inc.1986-01-01
MEDAJET XL - JET INJECTOR (K850754)Mada Medical Products, Inc.1985-12-10
DERATA MEDI-JECTOR PRO (K844244)Derata Corp.1985-07-05
VACUUM COMPRESSION INJECTOR (K851809)Uci Corp.1985-07-01
PRECI-JET 50 (K851181)Ulster Scientific, Inc.1985-06-06
NEW VITAJET (K851029)Andrew V. Stadler1985-05-23
DERATA MEDI-JECTOR III (K844111)Derata Corp.1984-11-28
VITAJET JET INSULIN INJECTION DEVICE (K843784)Vitajet Industriae Comercioltda.1984-11-02
MEDI-JECTOR II (K834044)Derata Corp.1984-03-06
MEDI-JECTOR (K772129)Derata Corp.1977-12-08

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Every clearance here is in the API, with alerts when new ones post.