KZH · Class II · 21 CFR 880.6920

FDA Product Code KZH: Introducer, Syringe Needle

Leading manufacturers include Medtronic Minimed, Scandinavian Health Limited and Hdc Corp..

47
Total
47
Cleared
116d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
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 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 Nov 08, 2004
INNOJECT AUTO-INJECTOR
K042557
Innoject, Inc.
General Hospital · 49d
Cleared Nov 10, 1999
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385
Owen Mumford USA, Inc.
General Hospital · 33d
Cleared Jul 29, 1999
QUICK-SERTER, MODEL 395
K992300
Medtronic Minimed
General Hospital · 21d
Cleared Jun 03, 1999
SOFTINJECT
K991680
Androsystems Srl
General Hospital · 17d
Cleared Jul 14, 1998
AUTO-INJECTOR, SURE-INJECT 2000
K981266
Mighty Mo, Corp.
General Hospital · 98d
Cleared May 29, 1998
B-D AUTO-INJECTOR
K974678
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 165d
Cleared Dec 19, 1997
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
K974171
Teva Medical, Ltd.
General Hospital · 44d
Cleared Mar 31, 1997
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479
Medtronic Minimed
General Hospital · 52d
Cleared Jun 10, 1996
POS-T-VAC ID-300
K961309
Pos-T-Vac, Inc.
General Hospital · 67d
Cleared Jan 29, 1996
PEN-INJECT 2.25
K954729
Scandinavian Health , Ltd.
General Hospital · 108d
Cleared Jun 23, 1995
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384
Hdc Corp.
General Hospital · 88d
Cleared Jan 20, 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473
Hdc Corp.
General Hospital · 73d
Cleared Apr 07, 1986
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K860284
Ulster Scientific, Inc.
General Hospital · 69d
Cleared Sep 12, 1983
MONOJECT INJECTOMATIC
K832683
Sherwood Medical Co.
General Hospital · 34d

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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.

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 →