Cleared Traditional

HEXIDIS ALCOHOL SWAB (K910735) - FDA 510(k) Clearance

K910735 · Specialites Septodont · General Hospital
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Apr 1991
Decision
40d
Days
-
Risk

K910735 is an FDA 510(k) clearance for the HEXIDIS ALCOHOL SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General Hospital 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 Specialites Septodont devices

Submission Details

510(k) Number K910735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date April 02, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -