Cleared Traditional

K250345 - Medline Bag Decanter (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250345 · Medline Industries, LP · General Hospital

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Oct 2025

Decision

260d

Days

Class 2

Risk

K250345 is an FDA 510(k) clearance for the Medline Bag Decanter. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on October 24, 2025 after a review of 260 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number	K250345 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 06, 2025
Decision Date	October 24, 2025
Days to Decision	260 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

132d slower than avg

Panel avg: 128d · This submission: 260d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LHI Set, I.v. Fluid Transfer
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.5440

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.