FOZ · Class II · 21 CFR 880.5200

FDA Product Code FOZ: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Under FDA product code FOZ, short-term intravascular therapeutic catheters are cleared for the delivery of medications and fluids directly into the vascular system.

These catheters provide temporary vascular access for the administration of drugs, fluids, blood products, or parenteral nutrition over periods of days to weeks. They include peripheral and central venous catheters used across inpatient and outpatient settings.

FOZ devices are Class II medical devices, regulated under 21 CFR 880.5200 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Becton Dickinson Infusion Therapy Systems, Inc., B.Braun Medical, Inc. and Becton, Dickinson and Company.

14
Total
14
Cleared
112d
Avg days
2021
Since

List of Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days devices cleared through 510(k)

14 devices
1–14 of 14
Cleared Oct 08, 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 154d
Cleared Jul 25, 2025
BD Nexiva™ Closed IV Catheter System
K243403
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 267d
Cleared Jul 11, 2025
BD Cathena™ Safety IV Catheter
K251155
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 88d
Cleared Jun 27, 2025
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
K251654
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 28d
Cleared Jun 03, 2025
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K250682
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 89d
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Dec 01, 2023
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K233529
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 147d
Cleared Jun 23, 2022
Introcan Safety 2 IV Catheter
K220756
B.Braun Medical, Inc.
General Hospital · 100d
Cleared May 14, 2022
Introcan Safety IV Catheter
K220626
B.Braun Medical, Inc.
General Hospital · 71d
Cleared Mar 31, 2022
BD Cathena Safety IV Catheter
K220584
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 30d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Oct 25, 2021
Introcan Safety 3 Closed IV Catheter
K213085
B.Braun Medical, Inc.
General Hospital · 31d
Cleared Jun 02, 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
K200891
Becton, Dickinson and Company
General Hospital · 425d

How to use this database

This page lists all FDA 510(k) submissions for Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days devices (product code FOZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →