Cleared Traditional

K833936 - ACETONE ALCOHOL SWABS (FDA 510(k) Clearance)

K833936 · Concord Laboratories, Inc. · General Hospital
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Jan 1984
Decision
76d
Days
-
Risk

K833936 is an FDA 510(k) clearance for the ACETONE ALCOHOL SWABS. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 76 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 Concord Laboratories, Inc. devices

Submission Details

510(k) Number K833936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1983
Decision Date January 30, 1984
Days to Decision 76 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
52d faster than avg
Panel avg: 128d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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