Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more— 510(k) K251676

Name: FDA 510(k) clearance K251676
Creator: U.S. Food and Drug Administration
Published: 2025-09-16

Substantially Equivalent

Microtek Medical, LLC

FDA 510(k) clearance K251676 for Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more, Substantially Equivalent on 2025-09-16. Applicant: Microtek Medical, LLC. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Microtek Medical, LLC
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2025-05-30
Decision date: 2025-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHI

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K252987 — ADRx Admixture Device2026-06-12
K260301 — Vial Adapter2026-06-05
K250345 — Medline Bag Decanter2025-10-24
K251715 — FlowArt® Vial Access Device Vented2025-10-14
K243404 — HyHub and HyHub Duo Vial Access Devices2025-07-18

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.