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IV Extension Sets with .22 Micron Filter

by Marquette Medical, Inc.

510(k) K905374

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 NumberK905374 Date31 May 1991ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is an IV extension set with an integrated 0.22-micron filter, classified under FDA product code FPA. It is designed to provide a sterile pathway for intravenous fluid administration while filtering out particulate matter to reduce the risk of microembolism during infusion.

The IV extension sets are intended for single-use in general hospital settings and are supplied sterile. They are regulated under FDA 510(k) clearance K905374, granted as substantially equivalent to a predicate device. Compliance with sterility and filtration specifications ensures safe use in intravenous therapy procedures.

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