Cleared Traditional

QUICKPAD (ALCOHOL SWABS) (K892193) - FDA 510(k) Clearance

K892193 · Holtsch Co., Inc. · General Hospital
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Aug 1989
Decision
121d
Days
-
Risk

K892193 is an FDA 510(k) clearance for the QUICKPAD (ALCOHOL SWABS). Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Holtsch Co., Inc. (Califon, US). The FDA issued a Cleared decision on August 4, 1989 after a review of 121 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 Holtsch Co., Inc. devices

Submission Details

510(k) Number K892193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date August 04, 1989
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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