Cleared Traditional

K912731 - STERI-SWAB

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

FDA 510(k) Submission Details - K912731

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.

LKB Device Classification - Class 0,

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

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

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