Cleared Traditional

K152884 - DermaTherapy Bed Linens (FDA 510(k) Clearance)

Class I General Hospital device.

K152884 · Precision Fabrics Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
264d
Days
Class 1
Risk

K152884 is an FDA 510(k) clearance for the DermaTherapy Bed Linens. Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Precision Fabrics Group, Inc. (Greensboro, US). The FDA issued a Cleared decision on June 20, 2016 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - 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 Precision Fabrics Group, Inc. devices

Submission Details

510(k) Number K152884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date June 20, 2016
Days to Decision 264 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
136d slower than avg
Panel avg: 128d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
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.