Atlas FDA

KZH

47 FDA 510(k) clearances · Product code

88 daysmedian time to decision
259 days90th percentile
47clearances measured

FDA profile

Official device name
Introducer, Syringe Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6920
Medical specialty
General Hospital
Adverse events (MAUDE)
2019: 95 · 2020: 158 · 2021: 87 · 2022: 58 · 2023: 35 · 2024: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
GripMate (K243232)Synthon Hispania S.L.2024-12-02
AccuSert Needle Inserter (K213429)Emed Technologies Corporation2022-10-20
Orbit Inserter (K163400)Ypsomed AG2017-07-26
MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
WHISPERJECT AUTOINJECTOR (K141384)Scandinavian Health Limited2014-09-12
LOBSTER AUTO-INJECTOR (K124026)Scandinavian Health Limited2013-09-13
AUTOJECT 2 FOR GLASSY SYRINGE (K122837)Owen Mumford, Ltd.2012-10-15
FLEXI-Q DV AND DVR AUTO-INJECTORS (K111467)Elcam Medical Acal2012-02-09
AUTO-SAFETY INJECTOR-2 (ASI-2) (K082587)Medical House Products Limited2008-10-02
COMPACT AUTO-SAFETY INJECTOR (CASI) (K073476)Medical House (Asi) Limited2008-03-07
DERMOTHERAP GUN (K062339)Dermoequipos S.R.L.2007-02-05
ACCU-CHEK LINKASSIST (K063146)Disetronic Medical Systems AG2006-11-27
DAI-R (K060141)Shl Medical, USA2006-06-12
CONFIDOSE IM AUTO-INJECTOR (K060389)Pharma-Pen, Inc.2006-06-06
EZ-JECT (K051667)Indolor, Ltd.2005-09-27
SHL DISPOSABLE AUTOINJECTOR (K050434)Shl Medical, USA2005-06-24
PERSONAL INJECTOR (K033696)Union Medico Aps2005-02-16
INNOJECT AUTO-INJECTOR (K042557)Innoject, Inc.2004-11-08
MEDSAFE SYSTEM INSERTER (K032848)Medsolve Technologies, LLC2004-04-12
INVISIJECT RESUSABLE AUTO-INJECTOR (K032425)Biogen2003-11-05
ANIMUS EZSERTER INFUSION SET INSERTER (K021700)Animas Corp.2002-06-04
AUTOJECT 2 (K013362)Owen Mumford USA, Inc.2001-11-13
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 (K010377)Minimed, Inc.2001-04-05
MODIFICATION TO AUTOJECT MINI (K000482)Owen Mumford, Ltd.2000-03-06
AUTOJET 2 (NON-FIXED NEEDLE TYPE) (K993385)Owen Mumford USA, Inc.1999-11-10
QUICK-SERTER, MODEL 395 (K992300)Medtronic Minimed1999-07-29
SOFTINJECT (K991680)Androsystems Srl1999-06-03
AUTO-INJECTOR, SURE-INJECT 2000 (K981266)Mighty Mo, Corp.1998-07-14
B-D AUTO-INJECTOR (K974678)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-05-29
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS (K974171)Teva Medical, Ltd.1997-12-19
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 (K970479)Medtronic Minimed1997-03-31
POS-T-VAC ID-300 (K961309)Pos-T-Vac, Inc.1996-06-10
PEN-INJECT 2.25 (K954729)Scandinavian Health , Ltd.1996-01-29
AUTOJECT MINI (K953735)Owen Mumford USA, Inc.1995-11-08
AUTOJECT 2 (K945660)Owen Mumford USA, Inc.1995-08-11
V-CATH PERCUTANEOUS INTRODUCER KIT (K951384)Hdc Corp.1995-06-23
V-CATH BREAKAWAY NEEDLE INTRODUCER (K945473)Hdc Corp.1995-01-20
SYRINGE NEEDLE INTRODUCER (K901803)Glaxo, Inc.1990-11-20
INSTAJECT II (K883164)Pavel Jordan & Associates, Inc.1988-10-04
INJECT-EASE (K872233)Palco Laboratories, Inc.1987-09-04
INSTAJECT (K870474)Pavel Jordan & Associates, Inc.1987-03-13
THE INJECTOR (K862325)American Medical Innovations, Inc.1987-02-27
DIAMATIC, AUTOMATIC INSULIN INJECTOR (K860284)Ulster Scientific, Inc.1986-04-07
MEDI-JECT (K832847)Jack H. Ritterskamp1984-02-28
INJECTION AIDE UNIT FOR DIAGETICS (K834440)Gottinger Co.1984-02-04
MONOJECT INJECTOMATIC (K832683)Sherwood Medical Co.1983-09-12
PISTORMATIC (K790104)Zelby, Burstein, Hartman & Burstein1979-05-14

Track KZH automatically

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