Medline Bag Decanter— 510(k) K250345

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K250345 for Medline Bag Decanter, Substantially Equivalent on 2025-10-24. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2025-02-06
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

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.