Cleared Traditional

K042722 - ALOCLAIR ORAL SPRAY (FDA 510(k) Clearance)

K042722 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2005
Decision
104d
Days
-
Risk

K042722 is an FDA 510(k) clearance for the ALOCLAIR ORAL SPRAY. Classified as Oral Wound Dressing (product code OLR).

Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on January 13, 2005 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sinclair Pharmaceuticals, Ltd. devices

Submission Details

510(k) Number K042722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date January 13, 2005
Days to Decision 104 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
10d faster than avg
Panel avg: 114d · This submission: 104d
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.