Chemo-Vent

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

510(k) Number

K860434 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Versa-Fill 120 & Fill Set 42-50

  Class II

  FDA 510(k) K850051 Active Cleared 6 Mar 1985

• Tamper Proof Cap

  Class II

  FDA 510(k) K861276 Active Cleared 5 May 1986

• What is the Chemo-Vent Filtered Venting Needle specifically designed to prevent during the venting of evacuated containers?

  The Chemo-Vent Filtered Venting Needle is designed to prevent contamination during the venting process by incorporating a 0.2-micron hydrophobic filter. This filter blocks microorganisms while allowing air to pass through, ensuring aseptic conditions are maintained. The non-coring bevel also helps protect the stopper from damage, reducing the risk of leaks or compromise to sterility.

• Is the Chemo-Vent Filtered Venting Needle reusable, and if not, how should it be handled to ensure safety?

  No, the Chemo-Vent Filtered Venting Needle is intended for single-use only. It comes with a sealed needle guard for safe handling, which helps prevent accidental needle sticks and maintains sterility until use. After use, the needle should be discarded as medical sharps waste to comply with infection control protocols.

• What gauge and length is the Chemo-Vent Filtered Venting Needle, and is it suitable for all types of evacuated containers?

  The Chemo-Vent Filtered Venting Needle is available in a 20-gauge, 1½-inch size. While this size is commonly used for standard evacuated containers (e.g., IV bags or blood collection systems), compatibility depends on the specific container’s stopper type and venting requirements. The non-coring bevel ensures minimal stopper damage, but users should verify the needle’s fit with their container system beforehand.

• How should the Chemo-Vent Filtered Venting Needle be stored to preserve its sterility and functionality?

  The Chemo-Vent Filtered Venting Needle is supplied sterile, so it must be stored in its original, unopened packaging to maintain sterility. Keep it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid exposing it to chemicals or contaminants that could compromise the filter or needle integrity. Always check the packaging for expiration or sterility indicators before use.

• What hospital settings is the Chemo-Vent Filtered Venting Needle approved for, and what regulatory pathway was followed?

  The Chemo-Vent Filtered Venting Needle is approved for use in hospital settings, specifically under the FDA 510(k) clearance pathway (K860434). It was classified under the General Hospital advisory committee (HO) and determined to be substantially equivalent to a predicate device. This clearance indicates it meets FDA requirements for safety and effectiveness as a filtered venting needle for evacuated containers.