E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970259 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• SafeStart Vascular Access Start Kit

  Class II

  FDA 510(k) K943941 Active Cleared 20 Oct 1994

• Angiocath(R) Nonvalon(R) and Angio-Set(R) IV Catheters

  Class II

  FDA 510(k) K950301 Active Cleared 18 Apr 1995

• Deseret(R) I.V. Loop and Deseret (R) J Loop

  Class II

  FDA 510(k) K950303 Active Cleared 14 Mar 1995

• Deseret Flow Restriction Valve

  Class II

  FDA 510(k) K914180 Active Cleared 8 May 1992

• Insyte Artcath Arterial Catheterization Unit

  Class II

  FDA 510(k) K921845 Active Cleared 10 Nov 1992

• First Midcath Catheter

  Class II

  FDA 510(k) K964050 Active Cleared 6 Jan 1997

See all devices from Becton Dickinson Vascular Access, Inc. →

• What is the E-Z Set Infusion Set / SAF-T designed for?

  This device is designed for peripheral intravenous infusion, delivering fluids, medications, or nutrients directly into a patient’s vein. Its low-profile design and secure spike mechanism ensure reliable fluid flow while reducing the risk of contamination during administration. The integrated tubing system with a built-in filter also helps prevent particulate matter from entering the patient’s circulation, making it suitable for standard intravenous therapy protocols in hospitals and outpatient environments.

• How is the E-Z Set Infusion Set / SAF-T supplied and stored?

  The device is supplied as a sterile, single-use item, packaged individually to maintain sterility until first use. No special storage conditions are required beyond protecting it from extreme temperatures and physical damage. This ensures readiness for immediate clinical use without additional preparation.

• Is the E-Z Set Infusion Set / SAF-T compatible with existing IV systems?

  Yes, it is designed to be compatible with standard intravenous administration systems commonly used in clinical settings. The secure spike mechanism and tubing design align with widely adopted protocols, allowing seamless integration into existing workflows for fluid, medication, or nutrient delivery.

• What safety features does the E-Z Set Infusion Set / SAF-T include?

  The infusion set features a low-profile design to minimize contamination risk during use. Its secure spike mechanism ensures a tight connection to intravenous bags or containers, reducing the likelihood of leaks or disconnections. Additionally, the built-in filter in the tubing system helps prevent particulate matter from entering the patient’s circulation, enhancing overall safety during infusion therapy.

• How is the regulatory status of this device determined?

  The E-Z Set Infusion Set / SAF-T holds FDA 510(k) clearance under the reference number K970259, with a predicate claim to earlier versions of the Becton Dickinson E-Z Set and SAF-T E-Z Set infusion sets. This clearance was granted under the Traditional 510(k) review pathway, confirming its substantial equivalence to predicate devices as evaluated by the FDA.