Cleared Traditional

K012126 - THE SALICEPT ORAL PATCH

K012126 · Carrington Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
89d
Days
-
Risk

K012126 is an FDA 510(k) clearance for the THE SALICEPT ORAL PATCH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 89 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.

FDA 510(k) Submission Details - K012126

510(k) Number K012126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date October 03, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
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 42
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K012126.
ORAMAGICRX ORAL WOUND RINSE
K024180 · Mpm Medical., Inc. · Mar 2003
ALOCLAIR ORAL RINSE
K023155 · Sinclair Pharmaceuticals, Ltd. · Nov 2002
GELCLAIR CONCENTRATED ORAL GEL
K013056 · Sinclair Pharmaceuticals, Ltd. · Dec 2001
ALOE THERAPY ORAL RINSE
K983182 · Carrington Laboratories, Inc. · Dec 1998
RADIACARE ORAL WOUND RINSE
K964852 · Carrington Laboratories, Inc. · Mar 1997
CASRRASYN ORAL WOUND DRESSING
K953423 · Carrington Laboratories, Inc. · Oct 1995
K012126 · THE SALICEPT ORAL PATCH
Download PDF FDA Summary Carrington Laboratori…