Cleared Traditional

K910735 - HEXIDIS ALCOHOL SWAB

K910735 · Specialites Septodont · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1991

Decision

40d

Days

Risk

K910735 is an FDA 510(k) clearance for the HEXIDIS ALCOHOL SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 40 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 Specialites Septodont devices

FDA 510(k) Submission Details - K910735

510(k) Number	K910735 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 21, 1991
Decision Date	April 02, 1991
Days to Decision	40 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

89d faster than avg

Panel avg: 129d · This submission: 40d

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 K910735.

BD ALCOHOL SWAB

K121655 · Becton, Dickinson & CO · Mar 2013

SITESCRUB IPA DEVICE

K112791 · C. R. Bard · Feb 2012

I.V. STARR KIT

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

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 K910735

Specialites Septodont

Washington, DC · US

PETER S REICHERTZ

Regulatory profile

21 submissions 21 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: April 2, 1991. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,972

Regulatory data since 1976

FDA monthly sync September 21, 2026