Prefilled Water for Irrigation USP

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

510(k) Number

K880316 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Prefilled Sodium Chloride Solution for Irriga. Usp

  Class II

  FDA 510(k) K880317 Active Cleared 29 Feb 1988

• Ster Inhal Solut Prefil Btl W/Adjust Entrain Nebul

  Class II

  FDA 510(k) K901301 Active Cleared 31 May 1990

• Prefilled Respiratory Therapy Vial

  Class II

  FDA 510(k) K830943 Active Cleared 28 Apr 1983

• Prefilled Sterile Water for Inhalation, Usp

  Class II

  FDA 510(k) K871618 Active Cleared 8 May 1987

• Tracheostomy & Nasal Suctioning Kit, 3C-Tns-1

  Class I

  FDA 510(k) K871692 Active Cleared 1 Jun 1987

• Respir Ther Humid Contain Sterile Water for Usp

  Class II

  FDA 510(k) K853146 Active Cleared 6 Aug 1985

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• What is the prefilled USP irrigation water used for?

  This device is designed as a sterile irrigation solution meeting USP standards, intended for medical procedures requiring clean, non-pyrogenic fluid. It is primarily used in clinical settings for wound cleaning, tracheostomy care, and other irrigation needs where maintaining sterility is critical to prevent contamination and support healing.

• How is the prefilled irrigation water supplied and should it be reused?

  The prefilled irrigation water comes in single-use containers, meaning each package is intended for one-time use only. This design ensures sterility and safety, as reuse could compromise the sterile field and introduce contamination risks. Always adhere to single-use guidelines to maintain proper infection control.

• What storage conditions are required to preserve sterility?

  To maintain sterility and integrity, the prefilled irrigation water must be stored in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or direct sunlight. Proper storage prevents degradation of the solution and ensures it remains safe for use when needed.

• Is this device approved for specific medical specialties?

  This prefilled irrigation water was reviewed by the FDA’s Anesthesiology Advisory Committee and is classified under product code BTO as a Class II medical device. While it is not limited to anesthesiology use, its regulatory pathway reflects its suitability for procedures where sterile irrigation is essential, including those in anesthesia-related contexts.

• Are there any special handling instructions for this device?

  The device is sterile as packaged, so avoid opening or handling it until immediate use. Do not use if the packaging is damaged or compromised. Since it is non-pyrogenic and intended for direct patient contact, ensure the solution is only used once and discard any unused portion after opening. No reusable components exist, and no MRI safety considerations are specified.