Cleared Traditional

STERI-SWAB (K912731) - FDA 510(k) Clearance

K912731 · Westlock Investments (Usa), Inc. · General Hospital
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Oct 1991
Decision
104d
Days
-
Risk

K912731 is an FDA 510(k) clearance for the STERI-SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Westlock Investments (Usa), Inc. (Bellevue, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 104 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 Westlock Investments (Usa), Inc. devices

Submission Details

510(k) Number K912731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1991
Decision Date October 02, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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