Product Code: KCY FDA class 1 21 CFR 878.5910

Tourniquet, Pneumatic

General, Plastic Surgery

A pneumatic tourniquet is a device used in surgical settings to apply controlled pressure to a limb to reduce blood flow to the operative field, improving visualization and reducing intraoperative blood loss during extremity surgery. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KCY is regulated under 21 CFR 878.5910 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

107

Registration Numbers

107

Unique Applicants

Years Active

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Basic Information

Product Code: KCY
Device Class: FDA class 1
Regulation Number: 878.5910
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K202919	ATS 5000 Automatic Tourniquet Instrument	May 20, 2021	Substantially Equivalent	Mcewen and Associates Consulting , Ltd.
K162365	T-Cuff	Feb 16, 2017	Substantially Equivalent	Terumobct, Inc.
K123553	ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM	Aug 09, 2013	Substantially Equivalent	Zimmer, Inc.
K112874	EZ VEIN INFLATABLE TOURNIQUET	Oct 17, 2011	Substantially Equivalent	Dominion Medical Devices, LLC
K071140	MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002	Jun 07, 2007	Substantially Equivalent	Top Spins, Inc.
K050411	ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM	Sep 02, 2005	Substantially Equivalent	Zimmer, Inc.
K012632	TOURNIQUET CUFF; PNEUMATIC TOURNIQUET	Oct 26, 2001	Substantially Equivalent	Medical Instruments Technology, Inc.
K955552	EXPRESSAIRE TORUNIQUET SYSTEM	Jan 05, 1996	Substantially Equivalent	Smith & Nephew Richards, Inc.
K954201	BUONAFEDE PNEUMATIC SLEEVE	Nov 09, 1995	Substantially Equivalent	Promedic, Inc.
K954103	TOURNI-COMP	Nov 01, 1995	Substantially Equivalent	Scandinavian Medical JW AB
K953953	DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF	Sep 29, 1995	Substantially Equivalent	Deroyal Industries, Inc.
K952038	CLEAN-CUFF	Jul 11, 1995	Substantially Equivalent	Instrumed, Inc.
K940615	ACCUTEST	May 19, 1995	Substantially Equivalent	Instrumed, Inc.
K945167	DJ MEDICAL PNEUMATIC TOURNIQUET	Feb 13, 1995	Substantially Equivalent	Dj Medical, Inc.
K942303	TECNADYNE T-CUFF	Jul 20, 1994	Substantially Equivalent	Technadyne Scientific, Inc.
K933994	ARTHREX TOURNIQUET FOR LEG HOLDER	Mar 23, 1994	Substantially Equivalent	Arthrex, Inc.
K925033	STILLE AUTOMATIC TOURNIQUET	Feb 01, 1993	Substantially Equivalent	Ferguson Medical
K924273	ACCUFLATE	Jan 12, 1993	Substantially Equivalent	Instrumed, Inc.
K910449	PRESTITCH	May 29, 1992	Substantially Equivalent	Crantec Co.
K910512	ACCUFLATE	Feb 19, 1991	Substantially Equivalent	Instrumed, Inc.
K900104	TCPM II TOURNIQUET CUFF PRESSURE MONITOR	Mar 15, 1990	Substantially Equivalent	Electromedics, Inc.
K890014	DISPOSABLE COLOR-CUFFS	Jan 24, 1989	Substantially Equivalent	Instrumed, Inc.
K880020	3 IN 1 AUTOMATIC TOURNIQUET	Mar 17, 1988	Substantially Equivalent	Systematics Mfg. & Tool Co., Inc.
K871982	TOURNIQUET PRESSURE REGULATOR	Jun 09, 1987	Substantially Equivalent	Avec Scientific Design Corp.
K870784	A.T.S. 1500 TOURNIQUET	Mar 18, 1987	Substantially Equivalent	Aspen Laboratories, Inc.
K860463	SINGLE AND DUAL TOURNIQUET CUFF	Feb 25, 1986	Substantially Equivalent	Aspen Laboratories, Inc.
K860095	DIGIKIT NONPNEUMATIC TOURNIQUET	Jan 24, 1986	Substantially Equivalent	Orthofab, Inc.
K853802	ATS 500 TOURNIQUET	Oct 07, 1985	Substantially Equivalent	Aspen Laboratories, Inc.
K842963	RHYS-DAVIES EXSANGUINATOR	Aug 17, 1984	Substantially Equivalent	Woodville Polymer Engineering, Ltd.
K841558	BANANA CUFF	Jul 16, 1984	Substantially Equivalent	Aspen Laboratories, Inc.
K840206	PRESSURE SENTRY TOURNIQUET	Apr 25, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K813231	TOURNIQUET	Dec 14, 1981	Substantially Equivalent	Aspen Laboratories, Inc.
K791759	TEST PRESSURE GAUGE #6675-32	Oct 04, 1979	Substantially Equivalent	Depuy, Inc.
K780988	DEVIN-NESTOR PNEUMATIC TOURNIQUET	Oct 03, 1978	Substantially Equivalent	Nestor Engineering Associates, Inc.