Cleared Traditional

K152884 - DermaTherapy Bed Linens

K152884 is an FDA 510(k) clearance for DermaTherapy Bed Linens, manufactured by Precision Fabrics Group, Inc.. The device is a Class 1 General Hospital device with product code FMW cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K152884 · Precision Fabrics Group, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K152884

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

FMW Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMW Cover, Mattress (medical Purposes)

All 10
Devices cleared under the same product code (FMW) and FDA review panel - the closest regulatory comparables to K152884.
DERMATHERAPY, MODEL 22216
K061242 · Precision Fabrics Group, Inc. · Jan 2007
Z-NET
K001003 · Demite Limited · Dec 2001
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
K992702 · Allergy Direct · Nov 1999
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
K940327 · W.L. Gore & Associates, Inc. · Feb 1994
CORE PREVENT MATTRESS MODIFICATION
K935220 · Paladin Medical, Inc. · Nov 1993
REUSABLE INCONTIENT UNDERPAD
K924807 · Perfect Fit Industries, Inc. · Feb 1993
K152884 · DermaTherapy Bed Linens
Download PDF FDA Summary Precision Fabrics Gro…