Cleared Traditional

K910735 - HEXIDIS ALCOHOL SWAB

K910735 · Specialites Septodont · General Hospital

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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

Submission Details

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

Regulatory Context

Review time vs. panel average

89d faster than avg

Panel avg: 129d · This submission: 40d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

All 7

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

I.V. STARR KIT

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

DRI-VENT ARTERIAL BLOOD SAMPLING KIT

K883840 · Concord Laboratories, Inc. · May 1989

PRE-MOISTENED CLEANSING PAD

K890514 · Bausch & Lomb, Inc. · Apr 1989

ACETONE ALCOHOL SWABS

K833936 · Concord Laboratories, Inc. · Jan 1984

ALCOHOL SWABS

K833993 · Concord Laboratories, Inc. · Jan 1984

Related FDA 510(k) Regulatory Insights

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

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Sourced from FDA 510(k) public files . Updated monthly.

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