Cleared Traditional

ONE TIME ACETONE/ALCOHOL (K833141) - FDA 510(k) Clearance

Also marketed or referenced as:
SWAB STICKS
K833141 · Acme United Corp. · General Hospital
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Oct 1983
Decision
47d
Days
-
Risk

K833141 is an FDA 510(k) clearance for the ONE TIME ACETONE/ALCOHOL. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 47 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 Acme United Corp. devices

Submission Details

510(k) Number K833141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date October 31, 1983
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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