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., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..

504
Total
504
Cleared
142d
Avg days
1976
Since
Growing category - 18 submissions in the last 2 years vs 14 in the prior period
Consistent review times: 147d avg (recent)

FDA 510(k) Cleared Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days Devices (Product Code FOZ)

504 devices
1–24 of 504
Cleared May 15, 2026
Introcan Safety® Deep Access XL IV Catheter
K253235
B.Braun Medical, Inc.
General Hospital · 228d
Cleared Apr 02, 2026
BD Insyte™ IV Catheter
K252137
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 268d
Cleared Apr 01, 2026
Polywin Safety (14G x 51mm
K252513
Poly Medicure Limited
General Hospital · 233d
Cleared Dec 17, 2025
SURFLO Hybria Closed System Safety IV Catheter
K252398
Terumo Medical Products Hangzhou Co., Ltd.
General Hospital · 139d
Cleared Nov 05, 2025
Polyshield Safety IV Catheters
K252677
Poly Medicure Limited
General Hospital · 72d
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 May 16, 2025
Ruby Intravascular Catheter
K243105
Venocare, Inc.
General Hospital · 228d
Cleared May 02, 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292
Skydance Vascular, Inc.
General Hospital · 91d
Cleared Mar 27, 2025
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059
Access Vascular, Inc.
General Hospital · 86d
Cleared Mar 14, 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
General Hospital · 113d
Cleared Dec 20, 2024
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
General Hospital · 140d
Cleared Nov 27, 2024
SV Spectrum MRC Central Venous Catheter
K241115
Spectrum Vascular
General Hospital · 218d
Cleared Jul 29, 2024
PowerGlide Pro™ Midline Catheter
K240359
Becton, Dickinson and Company (Bard Access Systems, Inc.)
General Hospital · 174d
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Apr 19, 2024
AccuCath Ace™ Intravascular Catheter
K233106
Bard Access Systems, Inc. (C.R. Bard, Inc.)
General Hospital · 205d
Cleared Mar 15, 2024
Nouvo Safety Set
K232234
Poly Medicure Limited
General Hospital · 232d
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 Sep 21, 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
K231401
Poly Medicure Limited
General Hospital · 129d
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
K223788
Medsource International, LLC
General Hospital · 270d

About Product Code FOZ - Regulatory Context

510(k) Submission Activity

504 total 510(k) submissions under product code FOZ since 1976, with 504 receiving FDA clearance (average review time: 142 days).

Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 14 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FOZ Product Code

FDA review times for FOZ submissions have been consistent, averaging 147 days recently vs 142 days historically.

FOZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →