Cleared Traditional

K110715 - INTERDRY SILVER

K110715 is an FDA 510(k) clearance for INTERDRY SILVER, manufactured by Milliken Healthcare Products, LLC. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K110715 · Milliken Healthcare Products, LLC · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K110715

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.

FRL Device Classification - Class 1, General Controls

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.

Regulatory Peers - FRL Fiber, Medical, Absorbent

All 10
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