Cleared Traditional

K121898 - STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (FDA 510(k) Clearance)

Class I General Hospital device.

K121898 · Quick-Med Technologies, Inc. · General Hospital
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May 2013
Decision
329d
Days
Class 1
Risk

K121898 is an FDA 510(k) clearance for the STAY FRESH SKIN FOLD MANAGEMENT TEXTILE. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Quick-Med Technologies, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 24, 2013 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Quick-Med Technologies, Inc. devices

Submission Details

510(k) Number K121898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date May 24, 2013
Days to Decision 329 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
201d slower than avg
Panel avg: 128d · This submission: 329d
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.