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Disposable Infusion Set

by Shan Dong Wei Gao Group Medical Polymer Products

510(k) K090012

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK090012 Date11 Jun 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1277-2015 FDA Class II initiated 10 Oct 2014

    Several complaints regarding the IV sets leaking at the Y site.

    • Terminated Z-2179-2012 FDA Class II initiated 3 Aug 2012

    Devices leaking at the Y-site

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  • Withdrawn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

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