CAZ · Class II · 21 CFR 868.5140

FDA Product Code CAZ: Anesthesia Conduction Kit

This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Medtronic Vascular and PAJUNK GmbH Medizintechnologie.

155
Total
155
Cleared
129d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Anesthesia Conduction Kit Devices (Product Code CAZ)

155 devices
1–24 of 155
Cleared Feb 13, 2023
Arrow 0.2 Micron Flat Filter, GVS
K222341
Arrow International, LLC
Anesthesiology · 194d
Cleared May 19, 2022
BD Epilor Syringe
K210983
Becton, Dickinson and Company
Anesthesiology · 413d
Cleared Feb 12, 2021
Plastic LOR Syringe
K201356
Jiangsu Caina Medical Co.,Ltd
Anesthesiology · 267d
Cleared Dec 29, 2020
E-Cath STIM acc. Tsui
K202699
PAJUNK GmbH Medizintechnologie
Anesthesiology · 104d
Cleared May 16, 2019
VPC
K190345
PAJUNK GmbH Medizintechnologie
Anesthesiology · 91d
Cleared May 20, 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 203d
Cleared Nov 30, 1995
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953790
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 108d
Cleared Oct 27, 1995
B-D SPINAL ANESTHESIA TRAY SPINAL
K953467
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 95d
Cleared Feb 13, 1995
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT
K945497
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 97d
Cleared Aug 27, 1993
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA
K932249
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 109d
Cleared Jan 14, 1993
B-D LOSS OF RESISTANCE SYRINGE
K925902
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 55d
Cleared Nov 28, 1989
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K896392
Medtronic Vascular
Anesthesiology · 22d
Cleared Sep 14, 1988
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394
Medtronic Vascular
Anesthesiology · 96d
Cleared Apr 21, 1988
AXILLARY BLOCK NEEDLE
K880970
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 44d

About Product Code CAZ - Regulatory Context

510(k) Submission Activity

155 total 510(k) submissions under product code CAZ since 1976, with 155 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.