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 Jiangsu Caina Medical Co.,Ltd and Becton, Dickinson and Company.

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

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

155 devices
1–24 of 155
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

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 2 in the prior period.

CAZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →