SafeStart Vascular Access Start Kit

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

510(k) Number

K943941 ↗

FDA Product Code

LRS

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 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

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

  Class II

  FDA 510(k) K970259 Active Cleared 8 Apr 1997

• First Midcath Catheter

  Class II

  FDA 510(k) K964050 Active Cleared 6 Jan 1997

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

• What types of clinical settings is the SafeStart Vascular Access Start Kit designed for, and why is this important for me as a clinician?

  The SafeStart Vascular Access Start Kit is specifically designed for use in general hospitals, as indicated by its regulatory filing under the 'General Hospital' advisory committee description. This means it is optimized for standard inpatient care where peripheral intravenous access is commonly required. As a clinician, this ensures the kit aligns with typical hospital workflows and patient needs, reducing the risk of complications like infiltration or phlebitis during catheter insertion.

• Is the SafeStart Vascular Access Start Kit reusable, or is it meant for single-use only? How does this affect its sterility?

  The SafeStart Vascular Access Start Kit is intended for single-use only, as explicitly stated in the description. This design ensures sterility is maintained throughout its intended use, minimizing infection risks. Single-use kits also eliminate the need for reprocessing, which can be time-consuming and may introduce contamination if not done properly.

• What catheter sizes are included in the SafeStart Vascular Access Start Kit, and how do I know which one to choose for a patient?

  While the exact catheter sizes aren’t listed in the provided data, the kit includes various catheter sizes to accommodate different patient needs, such as veins of varying sizes or age groups (e.g., pediatric to adult). The kit’s design emphasizes compatibility with diverse patient populations, so you would select the appropriate size based on clinical assessment—typically matching the vein’s diameter and patient’s age/condition—for optimal insertion and flow rates.

• How should I store the SafeStart Vascular Access Start Kit to ensure it remains effective and sterile until use?

  Since the kit is sterile and intended for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Check the packaging for any specific storage instructions (e.g., refrigeration if applicable), but generally, room-temperature storage is standard for sterile, single-use medical devices like this. Always verify the expiration date before use to ensure sterility and functionality.

• What regulatory pathway does the SafeStart Vascular Access Start Kit follow, and what does this mean for its safety and reliability?

  The kit holds an FDA 510(k) clearance under the classification of Class II medical devices, meaning it has undergone rigorous review to demonstrate substantial equivalence to a legally marketed predicate device. This pathway ensures the product meets established safety and performance standards for vascular access kits, giving clinicians confidence in its reliability for reducing complications like infiltration or phlebitis during peripheral IV insertion.