KZH · Class II · 21 CFR 880.6920

FDA Product Code KZH: Introducer, Syringe Needle

Leading manufacturers include Owen Mumford USA, Inc., Medtronic Minimed and Pavel Jordan & Associates, Inc..

47
Total
47
Cleared
116d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 54d recently vs 117d historically

FDA 510(k) Cleared Introducer, Syringe Needle Devices (Product Code KZH)

47 devices
1–24 of 47
Cleared Dec 02, 2024
GripMate
K243232
Synthon Hispania S.L.
General Hospital · 54d
Cleared Oct 20, 2022
AccuSert Needle Inserter
K213429
Emed Technologies Corporation
General Hospital · 364d
Cleared Jul 26, 2017
Orbit Inserter
K163400
Ypsomed AG
General Hospital · 233d
Cleared Sep 22, 2016
MiniMed Quick-serter
K160860
Medtronic Minimed
General Hospital · 177d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 13, 2013
LOBSTER AUTO-INJECTOR
K124026
Scandinavian Health Limited
General Hospital · 259d
Cleared Oct 15, 2012
AUTOJECT 2 FOR GLASSY SYRINGE
K122837
Owen Mumford, Ltd.
General Hospital · 28d
Cleared Feb 09, 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467
Elcam Medical Acal
General Hospital · 259d
Cleared Oct 02, 2008
AUTO-SAFETY INJECTOR-2 (ASI-2)
K082587
Medical House Products Limited
General Hospital · 24d
Cleared Mar 07, 2008
COMPACT AUTO-SAFETY INJECTOR (CASI)
K073476
Medical House (Asi) Limited
General Hospital · 88d
Cleared Feb 05, 2007
DERMOTHERAP GUN
K062339
Dermoequipos S.R.L.
General Hospital · 179d
Cleared Nov 27, 2006
ACCU-CHEK LINKASSIST
K063146
Disetronic Medical Systems AG
General Hospital · 42d
Cleared Jun 12, 2006
DAI-R
K060141
Shl Medical, USA
General Hospital · 144d
Cleared Jun 06, 2006
CONFIDOSE IM AUTO-INJECTOR
K060389
Pharma-Pen, Inc.
General Hospital · 112d
Cleared Sep 27, 2005
EZ-JECT
K051667
Indolor, Ltd.
General Hospital · 97d
Cleared Jun 24, 2005
SHL DISPOSABLE AUTOINJECTOR
K050434
Shl Medical, USA
General Hospital · 122d
Cleared Feb 16, 2005
PERSONAL INJECTOR
K033696
Union Medico Aps
General Hospital · 449d
Cleared Nov 08, 2004
INNOJECT AUTO-INJECTOR
K042557
Innoject, Inc.
General Hospital · 49d
Cleared Apr 12, 2004
MEDSAFE SYSTEM INSERTER
K032848
Medsolve Technologies, LLC
General Hospital · 213d
Cleared Nov 05, 2003
INVISIJECT RESUSABLE AUTO-INJECTOR
K032425
Biogen
General Hospital · 91d
Cleared Jun 04, 2002
ANIMUS EZSERTER INFUSION SET INSERTER
K021700
Animas Corp.
General Hospital · 12d
Cleared Nov 13, 2001
AUTOJECT 2
K013362
Owen Mumford USA, Inc.
General Hospital · 34d
Cleared Apr 05, 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377
Minimed, Inc.
General Hospital · 56d
Cleared Mar 06, 2000
MODIFICATION TO AUTOJECT MINI
K000482
Owen Mumford, Ltd.
General Hospital · 21d

About Product Code KZH - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code KZH since 1979, with 47 receiving FDA clearance (average review time: 116 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KZH Product Code

Recent submissions under KZH have taken an average of 54 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.

KZH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →