Cleared Traditional

ORAMAGICRX ORAL WOUND RINSE (K024180) - FDA 510(k) Clearance

K024180 · Mpm Medical., Inc. · General & Plastic Surgery device
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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.

View all Mpm Medical., Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 39
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K024180.
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