Cleared Traditional

K894791 - BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE

K894791 · Span-America Medical Systems, Inc. · General Hospital

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Oct 1989

Decision

67d

Days

Risk

K894791 is an FDA 510(k) clearance for the BAXTER ACETONE-ALCOHOL SWABSTICK, 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 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Span-America Medical Systems, Inc. devices

FDA 510(k) Submission Details - K894791

510(k) Number	K894791 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 1989
Decision Date	October 03, 1989
Days to Decision	67 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

62d faster than avg

Panel avg: 129d · This submission: 67d

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 13

Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K894791.

I.V. STARR KIT

K912161 · Medical Device Inspection Co., Inc. · Oct 1991

HEXIDIS ALCOHOL SWAB

K910735 · Specialites Septodont · Apr 1991

BAXTER ACETONE-ALCOHOL PREP PADS, STERILE

K893958 · 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

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 K894791

Span-America Medical Systems, Inc.

Greenville, SC · US

WANDA TOTTON

Regulatory profile

19 submissions 19 cleared

100% clearance rate · Active in General Hospital

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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