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Vial Vent Filter

by Baxter Healthcare Corp

510(k) K852467

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852467 Date17 Oct 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LHI
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vial Vent Filter is a sterile, single-use medical device designed as a vent for intravenous (IV) fluid administration systems. It allows air to escape from IV bags or containers while preventing contaminants from entering the fluid pathway, thereby maintaining the sterility of the infusion solution. This device is classified under the product code LHI and is intended for use in general hospital settings to enhance the safety of IV therapy by reducing the risk of air embolism.

The Vial Vent Filter is supplied as a sterile, disposable component and is regulated under FDA 510(k) clearance (K852467) with a traditional review process. It is intended for single-use only and must be discarded after use to prevent cross-contamination. The device is not intended for MRI use and requires proper storage in a clean, dry environment to preserve sterility. Baxter Healthcare Corp holds the authorization for this product, which was cleared for market in 1985 under the General Hospital advisory committee.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vial Vent Filter used for?

    The Vial Vent Filter is designed to vent air from intravenous (IV) fluid bags or containers during administration, ensuring air escapes while blocking contaminants from entering the fluid pathway. This helps maintain the sterility of the infusion solution and reduces the risk of air embolism, a serious complication in IV therapy.

  • Is the Vial Vent Filter reusable or single-use?

    The Vial Vent Filter is intended for single-use only. After use, it must be discarded to prevent cross-contamination and maintain patient safety. Reusing this device could compromise sterility and increase infection risks.

  • How should the Vial Vent Filter be stored?

    The device must be stored in a clean, dry environment to preserve its sterility. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could degrade the filter’s integrity or introduce contaminants.

  • Can the Vial Vent Filter be used with MRI equipment?

    No, the Vial Vent Filter is not intended for MRI use. Its materials and design are not compatible with magnetic resonance imaging environments, which could interfere with device performance or safety.

  • What regulatory clearance does the Vial Vent Filter hold?

    The Vial Vent Filter holds FDA 510(k) clearance (K852467) under the product code LHI, with a traditional review process. It was cleared for market in 1985 under the General Hospital advisory committee (HO). The clearance confirms it meets U.S. safety and performance standards for its intended use.