Cleared Traditional

INTERDRY TEXTILE WITH SILVER (K061615) - FDA 510(k) Clearance

Class I General Hospital device.

K061615 · Milliken Chemical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
196d
Days
Class 1
Risk

K061615 is an FDA 510(k) clearance for the INTERDRY TEXTILE WITH SILVER. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Milliken Chemical (North Attleboro, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 196 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 Chemical devices

Submission Details

510(k) Number K061615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date December 22, 2006
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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.