Cleared Traditional

K851026 - MOI-STIR ORAL SWABSTICK(S)

K851026 · Kingswood Laboratories, Inc. · Dental device
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May 1985
Decision
70d
Days
-
Risk

K851026 is an FDA 510(k) clearance for the MOI-STIR ORAL SWABSTICK(S). Classified as Saliva, Artificial (product code LFD).

Submitted by Kingswood Laboratories, Inc. (Carmel, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental 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 Kingswood Laboratories, Inc. devices

FDA 510(k) Submission Details - K851026

510(k) Number K851026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 21, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -