Cleared Traditional

K024180 - ORAMAGICRX ORAL WOUND RINSE

K024180 · Mpm Medical., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
86d
Days
-
Risk

K024180 is an FDA 510(k) clearance for the ORAMAGICRX ORAL WOUND RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Mpm Medical., Inc. (Belleville, US). The FDA issued a Cleared decision on March 14, 2003 after a review of 86 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 - K024180

510(k) Number K024180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2002
Decision Date March 14, 2003
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 K024180.
ALOCLAIR ORAL SPRAY
K042722 · Sinclair Pharmaceuticals, Ltd. · Jan 2005
MUCOTROL CONCENTRATED ORAL GEL WAFER
K042400 · Belcher Pharmaceuticals, Inc. · Nov 2004
ALOCLAIR ORAL GEL
K040950 · Sinclair Pharmaceuticals, Ltd. · Jun 2004
ALOCLAIR ORAL RINSE
K023155 · Sinclair Pharmaceuticals, Ltd. · Nov 2002
GELCLAIR CONCENTRATED ORAL GEL
K013056 · Sinclair Pharmaceuticals, Ltd. · Dec 2001
THE SALICEPT ORAL PATCH
K012126 · Carrington Laboratories, Inc. · Oct 2001
K024180 · ORAMAGICRX ORAL WOUND RINSE
Download PDF FDA Summary Mpm Medical., Inc.