Flex-Iv

FDA 510(k) K911251 · Medway

Substantially Equivalent

510(k) numberK911251

Submission

Device name
Flex-Iv
Applicant
Medway
Franklin, TN, US
Received
March 21, 1991
Decision date
October 28, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Specialty
General Hospital

Other 510(k)s with product code FOZ

510(k)DeviceApplicantDecision
K260432Ruby Intravascular CatheterFOZ · Traditional Venocare, Inc.09/02/2026SE
K260165Unimpregnated Central Venous CatheterFOZ · Traditional Spectrum Vascular08/10/2026SE
K261041ClearSafe Closed SystemFOZ · Traditional MedSource Labs, LLC07/10/2026SE
K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterFOZ · Traditional MedSource Labs, LLC07/09/2026SE
K253235Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional B.Braun Medical, Inc.05/15/2026SE
K252137BD Insyte™ IV CatheterFOZ · Traditional Becton Dickinson Infusion Therapy Systems, Inc.04/02/2026SE
K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special Poly Medicure Limited04/01/2026SE
K252398SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional Terumo Medical Products (Hangzhou) Co., Ltd.12/17/2025SE
K252677Polyshield Safety IV CathetersFOZ · Special Poly Medicure Limited11/05/2025SE
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemFOZ · Traditional Becton Dickinson Infusion Therapy Systems, Inc.10/08/2025SE

More from Becton Dickinson Infusion Therapy Systems, Inc.

510(k)DeviceDecision
K934344Home Amb-AlertKMI · Traditional 04/29/1994SE
K931952Medway Oxygen MaskBYG · Traditional 08/20/1993SE
K911079Amb-AlertKMI · Traditional 09/13/1991SE
K910880Comfor-BoardKMK · Traditional 06/06/1991SE

Questions and answers

When was Flex-Iv cleared by the FDA?

Flex-Iv (K911251) received a 510(k) decision of Substantially Equivalent on October 28, 1991, 221 days after the submission was received.

What is the product code of K911251?

The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.