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Winged Infusion Sets

by An-Med Intl.

510(k) K852989

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 NumberK852989 Date26 Jul 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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Winged infusion sets are medical devices used for intravenous administration of fluids or medications. They consist of a needle with wings for stabilization and tubing connected to a port for connection to an IV line.

These devices are supplied in various sizes including 18G x 3/4-in and 19G x 3/4-in configurations. They are typically packaged in boxes of 50 units and are intended for single-use. The device received FDA 510(k) clearance with K number K852989 on July 26, 1985.

Other devices from An-Med Intl.

Questions

AI-generated answers, 25 Sep 2026

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

  • What are winged infusion sets used for?

    Winged infusion sets are used for intravenous administration of fluids or medications, providing stabilization via wings on the needle.

  • How are winged infusion sets supplied?

    They are supplied in boxes of 50 units, in various sizes including 18G x 3/4-in and 19G x 3/4-in configurations.

  • Are winged infusion sets reusable?

    No, winged infusion sets are intended for single-use.