Cleared Traditional

K893958 - BAXTER ACETONE-ALCOHOL PREP PADS, STERILE

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.

FDA 510(k) Submission Details - K893958

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

5d faster than avg

Panel avg: 129d · This submission: 124d

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 24

Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K893958.

HEXIDIS ALCOHOL SWAB

K910735 · Specialites Septodont · Apr 1991

BOWEN ELECTRODE SKIN PREPATORY CLEANSER

K896898 · Bowen & Company, Inc. · Apr 1990

ALCOHOL PREP AND POVIDONE-IODINE PREP

K896835 · Norpak Mfg., Inc. · Jan 1990

BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE

K894791 · Span-America Medical Systems, Inc. · Oct 1989

QUICKPAD (ALCOHOL SWABS)

K892193 · Holtsch Co., Inc. · Aug 1989

DRI-VENT ARTERIAL BLOOD SAMPLING KIT

K883840 · Concord Laboratories, Inc. · May 1989

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K893958

Span-America Medical Systems, Inc.

Greenville, SC · US

WANDA J TOTTON

Regulatory profile

19 submissions 19 cleared

100% clearance rate · Active in General Hospital

View all devices by Span-America Medical Systems, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 3, 1989. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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