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)— 510(k) K251676

Substantially Equivalent

Microtek Medical, LLC

FDA 510(k) clearance K251676 for 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), Substantially Equivalent on 2025-09-16. Applicant: Microtek Medical, LLC.

Clearance details

Applicant: Microtek Medical, LLC
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2025-05-30
Decision date: 2025-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

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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.