Cleared Traditional

ALOCLAIR ORAL RINSE (K023155) - FDA 510(k) Clearance

K023155 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
63d
Days
-
Risk

K023155 is an FDA 510(k) clearance for the ALOCLAIR ORAL RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on November 25, 2002 after a review of 63 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 Sinclair Pharmaceuticals, Ltd. devices

Submission Details

510(k) Number K023155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date November 25, 2002
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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
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