Cleared Traditional

K023046 - SST SALIVA SUPPORTING TABLETS

K023046 is an FDA 510(k) clearance for SST SALIVA SUPPORTING TABLETS, manufactured by Sinclair Pharmaceuticals, Ltd.. The device is a Class 1 Pathology device with product code LED cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K023046 · Sinclair Pharmaceuticals, Ltd. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
81d
Days
Class 1
Risk

K023046 is an FDA 510(k) clearance for the SST SALIVA SUPPORTING TABLETS. Classified as Stains, Chemical Solution (product code LED), Class I - General Controls.

Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on December 2, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology device framework. 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

FDA 510(k) Submission Details - K023046

510(k) Number K023046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date December 02, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 77d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

LED Device Classification - Class 1, General Controls

Product Code LED Stains, Chemical Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LED Stains, Chemical Solution

All 7
Devices cleared under the same product code (LED) and FDA review panel - the closest regulatory comparables to K023046.
SPOTTEST CALCOFLUOR WHITE REAGENT
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K842930 · E K Ind., Inc. · Sep 1984
SUPERMOUNT
K842727 · E K Ind., Inc. · Aug 1984
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K833388 · Sigma Chemical Co. · Oct 1983