Cleared Traditional

K892193 - QUICKPAD (ALCOHOL SWABS)

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

FDA 510(k) Submission Details - K892193

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.

LKB Device Classification - Class 0,

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

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

All 14
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K892193.
HEXIDIS ALCOHOL SWAB
K910735 · Specialites Septodont · Apr 1991
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · Span-America Medical Systems, Inc. · Oct 1989
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · Span-America Medical Systems, Inc. · Oct 1989
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · Concord Laboratories, Inc. · May 1989
PRE-MOISTENED CLEANSING PAD
K890514 · Bausch & Lomb, Inc. · Apr 1989
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K870718 · Span-America Medical Systems, Inc. · May 1987