FDA Product Code KZH: Introducer, Syringe Needle
Leading manufacturers include Synthon Hispania S.L., Bd Becton Dickinson Vacutainer Systems Preanalytic and Emed Technologies Corporation.
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
Cleared
Dec 02, 2024
GripMate
Synthon Hispania S.L.
General Hospital
54d
Cleared
Oct 20, 2022
AccuSert Needle Inserter
Emed Technologies Corporation
General Hospital
364d
Cleared
May 29, 1998
B-D AUTO-INJECTOR
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
165d
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 →