Cleared Traditional

GAMMA RADIATION STERILIZED ALCOHOL PREP PADS (K860961) - FDA 510(k) Clearance

K860961 · H & P Industries, Inc. · General Hospital
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Apr 1986
Decision
27d
Days
-
Risk

K860961 is an FDA 510(k) clearance for the GAMMA RADIATION STERILIZED ALCOHOL PREP PADS. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by H & P Industries, Inc. (Franklin, US). The FDA issued a Cleared decision on April 9, 1986 after a review of 27 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 H & P Industries, Inc. devices

Submission Details

510(k) Number K860961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date April 09, 1986
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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