Cleared Traditional

K042400 - MUCOTROL CONCENTRATED ORAL GEL WAFER

K042400 · Belcher Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
82d
Days
-
Risk

K042400 is an FDA 510(k) clearance for the MUCOTROL CONCENTRATED ORAL GEL WAFER. Classified as Oral Wound Dressing (product code OLR).

Submitted by Belcher Pharmaceuticals, Inc. (Largo, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 82 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 - K042400

510(k) Number K042400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2004
Decision Date November 24, 2004
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K042400.
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
K060363 · Hemcon, Inc. · Jul 2006
ORAMAGIC PLUS ORAL WOUND RINSE
K060340 · Mpm Medical., Inc. · May 2006
ALOCLAIR ORAL SPRAY
K042722 · Sinclair Pharmaceuticals, Ltd. · Jan 2005
ALOCLAIR ORAL GEL
K040950 · Sinclair Pharmaceuticals, Ltd. · Jun 2004
ORAMAGICRX ORAL WOUND RINSE
K024180 · Mpm Medical., Inc. · Mar 2003
ALOCLAIR ORAL RINSE
K023155 · Sinclair Pharmaceuticals, Ltd. · Nov 2002
K042400 · MUCOTROL CONCENTRATED ORAL GEL WAFER
Download PDF FDA Summary Belcher Pharmaceutica…