Cleared Traditional

BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (K893958) - FDA 510(k) Clearance

K893958 · Span-America Medical Systems, Inc. · General Hospital
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Oct 1989
Decision
124d
Days
-
Risk

K893958 is an FDA 510(k) clearance for the BAXTER ACETONE-ALCOHOL PREP PADS, STERILE. 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 October 3, 1989 after a review of 124 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K893958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1989
Decision Date October 03, 1989
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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