Sterile I.V. Start Kit

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

510(k) Number

K902810 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SEKD

• Pre-Filled Sysringe W/Sterile Water

  Class II

  FDA 510(k) K943829 Active Cleared 21 Nov 1994

• Dual Port Enteral Y-Adaptor

  Class II

  FDA 510(k) K923168 Active Cleared 17 Jun 1994

• External Leg Bag

  Class I

  FDA 510(k) K901219 Active Cleared 27 Jun 1990

• Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride Solution

  Class II

  CE/MDR FDA 510(k) K943830 Active Cleared 21 Nov 1994

• Bulb Irrigation Tray

  Class II

  FDA 510(k) K900736 Active Cleared 17 Apr 1990

• Suction Catheter, Sterile

  Class I

  FDA 510(k) K902814 Active Cleared 17 Aug 1990

See all devices from Orion Life Systems, Inc. →

• What is the Sterile I.V. Start Kit used for?

  The Sterile I.V. Start Kit is designed specifically for initiating peripheral intravenous (IV) lines in clinical settings. It includes components to prepare and insert an IV catheter while maintaining aseptic technique, ensuring a clean and controlled procedure to reduce infection risk. This makes it ideal for hospitals and outpatient care facilities where quick, reliable IV access is required.

• Is the kit single-use or reusable?

  This kit is intended for single-use only. The sterile packaging ensures safety and compliance with medical standards, preventing contamination or cross-infection if reused. After use, the entire kit should be discarded to maintain sterility and regulatory adherence.

• What storage conditions are required for the Sterile I.V. Start Kit?

  No special storage conditions are specified beyond preserving sterility until use. The kit should be stored in its original packaging, protected from moisture, extreme temperatures, and physical damage. Once opened, the kit must be used immediately to avoid compromising its sterile integrity.

• Does the kit require any additional regulatory approvals beyond FDA clearance?

  The Sterile I.V. Start Kit holds an FDA 510(k) clearance (K902810) under traditional review, confirming compliance with U.S. Class II medical device standards. No additional MRI safety or reusable specifications are noted, meaning it is not intended for reuse or use in MRI environments. Always verify local regulations if deploying outside the U.S.

• How is the kit supplied, and what components does it include?

  The kit is supplied in a sterile package for single-use, containing all necessary components for IV catheter insertion, including sterile drapes, catheter, and accessories to facilitate aseptic technique. The exact contents may vary, but the packaging ensures everything remains uncontaminated until use. Check the labeling for specific itemization.