Cleared Traditional

AMERICAN ALCOHOL PREP PAD STERILE MEDIUM (K870718) - FDA 510(k) Clearance

K870718 · Span-America Medical Systems, Inc. · General Hospital
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May 1987
Decision
76d
Days
-
Risk

K870718 is an FDA 510(k) clearance for the AMERICAN ALCOHOL PREP PAD STERILE MEDIUM. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on May 7, 1987 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 Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K870718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1987
Decision Date May 07, 1987
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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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