Cleared Traditional

APLICARE ONE ACETONE ALCOHOL SWABSTICK (K833183) - FDA 510(k) Clearance

K833183 · Aplicare, Inc. · General Hospital
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Oct 1983
Decision
42d
Days
-
Risk

K833183 is an FDA 510(k) clearance for the APLICARE ONE ACETONE ALCOHOL SWABSTICK. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Aplicare, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 42 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 Aplicare, Inc. devices

Submission Details

510(k) Number K833183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date October 31, 1983
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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