Cleared Traditional

K082856 - CARAPASTE ORAL WOUND DRESSING

K082856 · Mcgrath Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
16d
Days
-
Risk

K082856 is an FDA 510(k) clearance for the CARAPASTE ORAL WOUND DRESSING. Classified as Oral Wound Dressing (product code OLR).

Submitted by Mcgrath Pharmaceuticals, Inc. (Grayslake, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mcgrath Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K082856

510(k) Number K082856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date October 15, 2008
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 19
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K082856.
Orapeutic
K191987 · Forward Science · Nov 2019
OraCure
K183436 · Tbm Corporation · Sep 2019
SUNTOUCH Dental Dressing
K173196 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2018
ALOE THERAPY ORAL RINSE
K983182 · Carrington Laboratories, Inc. · Dec 1998
RADIACARE ORAL WOUND RINSE
K964852 · Carrington Laboratories, Inc. · Mar 1997