Cleared Traditional

APLICARE THREE ALCOHOL SWABSTICKS (K833184) - FDA 510(k) Clearance

K833184 · Aplicare, Inc. · General Hospital
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Oct 1983
Decision
38d
Days
-
Risk

K833184 is an FDA 510(k) clearance for the APLICARE THREE ALCOHOL SWABSTICKS. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Aplicare, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 38 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 K833184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date October 27, 1983
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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