Solution Administration Tip Protector

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

510(k) Number

K781813 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the Solution Administration Tip Protector used for?

  The Solution Administration Tip Protector is designed to cover and protect the infusion tip of administration sets during intravenous procedures. Its primary purpose is to prevent contamination of the tip and accidental dislodgement, ensuring a sterile connection between the administration set and the patient’s vein or catheter. This helps maintain the integrity of the infusion line and reduces the risk of infection or fluid leakage.

• Is the Tip Protector compatible with all infusion administration sets?

  The Tip Protector is specifically designed to be compatible with standard infusion administration sets. It is intended to fit securely over the tip of these sets, providing protection without requiring modifications to the set itself. Always verify compatibility with the specific infusion system in use, as variations in design may affect fit.

• How is the Tip Protector supplied, and what are its sterility and usage instructions?

  The Tip Protector is supplied sterile and intended for single-use in hospital settings. After opening the sterile packaging, it should be immediately attached to the infusion set’s tip before use. Once applied, it should remain in place throughout the infusion procedure to maintain sterility and prevent contamination. Discard the protector after use to avoid cross-contamination.

• Are there any special storage requirements for the Tip Protector?

  The Tip Protector does not require any additional storage conditions beyond those recommended for the associated infusion system. Store it in its original, sealed packaging until ready for use to preserve sterility. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these factors could compromise the device’s integrity.

• What regulatory clearance does the Tip Protector hold?

  The Solution Administration Tip Protector has received FDA 510(k) clearance under the reference number K781813. This clearance classifies it as a Class II medical device, adhering to traditional review standards. The device is intended for use as an infusion-related accessory and is authorized for distribution in the United States.