Home / 510(k) Clearances / K251676

510(k) K251676

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) by Microtek Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2025
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Microtek Medical, LLC

  • K110358 — VENODYNE V810 (May 5, 2011)
  • K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (February 23, 2011)
  • K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA (January 25, 2007)
  • K060200 — MICROTEK MEDICAL WARMING DRAPE (May 31, 2006)
  • K050322 — MICROTEK EQUIPMENT DRAPES (May 17, 2005)
  • K022903 — CHILLBUSTER (November 27, 2002)
  • K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (May 16, 2002)
  • K011318 — VENODYNE DVT ADVANTAGE PLUS (October 25, 2001)
  • K001802 — VENODYNE DVT ADVANTAGE MODEL 610 (January 9, 2001)
  • K950906 — LESINSKI SURGICAL EAR DRESSING (June 22, 1995)

Other clearances for product code LHI

  • K250345 — Medline Bag Decanter (October 24, 2025)
  • K251715 — FlowArt® Vial Access Device Vented (October 14, 2025)
  • K243404 — HyHub™ and HyHub™ Duo Vial Access Devices (July 18, 2025)
  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K243486 — SmartSiteTM Vented Vial Access Device (December 6, 2024)
  • K241976 — nextaro® va, 15mm, 5µm (September 6, 2024)
  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K232987 — FlowArt Valve for Vial Access (June 26, 2024)
  • K240940 — Vial2Bag Advanced® 20mm Admixture Device (May 3, 2024)