Cleared Traditional

K111577 - MEDLINE VIAL DECANTER

K111577 is the FDA 510(k) clearance for MEDLINE VIAL DECANTER by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K111577 · Medline Industries, Inc. · General Hospital
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Sep 2011
Decision
93d
Days
Class 2
Risk

K111577 is an FDA 510(k) clearance for the MEDLINE VIAL DECANTER. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 8, 2011 after a review of 93 days - within the typical 510(k) review window.

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.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K111577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2011
Decision Date September 08, 2011
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
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.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 67
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K111577.
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K092318 · Baxter Healthcare Corporation · Oct 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009