Cleared Traditional

K110715 - INTERDRY SILVER (FDA 510(k) Clearance)

Class I General Hospital device.

K110715 · Milliken Healthcare Products, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2011
Decision
234d
Days
Class 1
Risk

K110715 is an FDA 510(k) clearance for the INTERDRY SILVER. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Milliken Healthcare Products, LLC (Spartanburg, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 234 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5300 - 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 Milliken Healthcare Products, LLC devices

Submission Details

510(k) Number K110715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2011
Decision Date November 04, 2011
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 129d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRL Fiber, Medical, Absorbent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.