Cleared Traditional

K964852 - RADIACARE ORAL WOUND RINSE

K964852 · Carrington Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
-
Risk

K964852 is an FDA 510(k) clearance for the RADIACARE ORAL WOUND RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 90 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.

FDA 510(k) Submission Details - K964852

510(k) Number K964852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date March 03, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K964852.
GELCLAIR CONCENTRATED ORAL GEL
K013056 · Sinclair Pharmaceuticals, Ltd. · Dec 2001
THE SALICEPT ORAL PATCH
K012126 · Carrington Laboratories, Inc. · Oct 2001
ALOE THERAPY ORAL RINSE
K983182 · Carrington Laboratories, Inc. · Dec 1998
CASRRASYN ORAL WOUND DRESSING
K953423 · Carrington Laboratories, Inc. · Oct 1995
CARRASYN ORAL WOUND DRESSING
K933741 · Carrington Laboratories, Inc. · May 1994
K964852 · RADIACARE ORAL WOUND RINSE
Download PDF FDA Summary Carrington Laboratori…