Product Code: LKB FDA unclassified

Pad, Alcohol, Device Disinfectant

Unknown

Pad, Alcohol, Device Disinfectant is a pre-moistened pad containing isopropyl or ethyl alcohol used for disinfecting medical device surfaces and skin prior to procedures. This device is currently unclassified by the FDA, meaning it has not been formally assigned to Class 1, 2, or 3, and its regulatory pathway is pending determination. The product code is LKB; no regulation number or medical specialty has been assigned. The review panel is General Hospital.

View on FDA

510(k)s

FEI Numbers

113

Registration Numbers

113

Unique Applicants

Years Active

Research product code LKB in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LKB
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: HO
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132380	PREVANTICS DEVICE SWAB	Aug 27, 2014	Substantially Equivalent	Professional Disposables International, Inc.
K121655	BD ALCOHOL SWAB	Mar 20, 2013	Substantially Equivalent	Becton, Dickinson & CO
K112791	SITESCRUB IPA DEVICE	Feb 24, 2012	Substantially Equivalent	C. R. Bard
K912161	I.V. STARR KIT	Oct 08, 1991	Substantially Equivalent	Medical Device Inspection Co., Inc.
K912731	STERI-SWAB	Oct 02, 1991	Substantially Equivalent	Westlock Investments (Usa), Inc.
K910735	HEXIDIS ALCOHOL SWAB	Apr 02, 1991	Substantially Equivalent	Specialites Septodont
K896898	BOWEN ELECTRODE SKIN PREPATORY CLEANSER	Apr 04, 1990	Substantially Equivalent	Bowen & Company, Inc.
K896835	ALCOHOL PREP AND POVIDONE-IODINE PREP	Jan 11, 1990	Substantially Equivalent	Norpak Mfg., Inc.
K894791	BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE	Oct 03, 1989	Substantially Equivalent	Span-America Medical Systems, Inc.
K893958	BAXTER ACETONE-ALCOHOL PREP PADS, STERILE	Oct 03, 1989	Substantially Equivalent	Span-America Medical Systems, Inc.
K892193	QUICKPAD (ALCOHOL SWABS)	Aug 04, 1989	Substantially Equivalent	Holtsch Co., Inc.
K883840	DRI-VENT ARTERIAL BLOOD SAMPLING KIT	May 16, 1989	Unknown	Concord Laboratories, Inc.
K890514	PRE-MOISTENED CLEANSING PAD	Apr 10, 1989	Substantially Equivalent	Bausch & Lomb, Inc.
K870718	AMERICAN ALCOHOL PREP PAD STERILE MEDIUM	May 07, 1987	Substantially Equivalent	Span-America Medical Systems, Inc.
K860961	GAMMA RADIATION STERILIZED ALCOHOL PREP PADS	Apr 09, 1986	Substantially Equivalent	H & P Industries, Inc.
K852235	STERETS INJECTION SWAB	Jun 07, 1985	Substantially Equivalent	Ellis Pharmaceutical Consulting, Inc.
K833993	ALCOHOL SWABS	Jan 30, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K833936	ACETONE ALCOHOL SWABS	Jan 30, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K833185	ACETONE ALCOHOL PREP PAD	Oct 31, 1983	Substantially Equivalent	Aplicare, Inc.
K833183	APLICARE ONE ACETONE ALCOHOL SWABSTICK	Oct 31, 1983	Substantially Equivalent	Aplicare, Inc.
K833141	ONE TIME ACETONE/ALCOHOL;SWAB STICKS	Oct 31, 1983	Substantially Equivalent	Acme United Corp.
K833184	APLICARE THREE ALCOHOL SWABSTICKS	Oct 27, 1983	Substantially Equivalent	Aplicare, Inc.
K833182	APLICARE ALCOHOL PREP PAD	Oct 27, 1983	Substantially Equivalent	Aplicare, Inc.
K830330	SAVETT ALCOHOL PREP	Mar 17, 1983	Substantially Equivalent	Cederroth, Inc. USA
K813391	TOBRAMYCIN REAGENT TEST KIT	Dec 18, 1981	Substantially Equivalent	Beckman Instruments, Inc.