Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5910](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5910) → KCY — Tourniquet, Pneumatic # KCY · Tourniquet, Pneumatic _General, Plastic Surgery · 21 CFR 878.5910 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY ## Overview - **Product Code:** KCY - **Device Name:** Tourniquet, Pneumatic - **Regulation:** [21 CFR 878.5910](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5910) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. ## Recent Cleared Devices (20 of 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K202919](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K202919.md) | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | May 20, 2021 | SESE | | [K162365](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K162365.md) | T-Cuff | Terumobct, Inc. | Feb 16, 2017 | SESE | | [K123553](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K123553.md) | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | Aug 9, 2013 | SESE | | [K112874](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K112874.md) | EZ VEIN INFLATABLE TOURNIQUET | Dominion Medical Devices, LLC | Oct 17, 2011 | SESE | | [K071140](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K071140.md) | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | Top Spins, Inc. | Jun 7, 2007 | SESE | | [K050411](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K050411.md) | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | Sep 2, 2005 | SESE | | [K012632](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K012632.md) | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | Oct 26, 2001 | SESE | | [K955552](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K955552.md) | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | Jan 5, 1996 | SESE | | [K954201](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K954201.md) | BUONAFEDE PNEUMATIC SLEEVE | Promedic, Inc. | Nov 9, 1995 | SESE | | [K954103](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K954103.md) | TOURNI-COMP | Scandinavian Medical JW AB | Nov 1, 1995 | SESE | | [K953953](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K953953.md) | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | Sep 29, 1995 | SESE | | [K952038](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K952038.md) | CLEAN-CUFF | Instrumed, Inc. | Jul 11, 1995 | SESE | | [K940615](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K940615.md) | ACCUTEST | Instrumed, Inc. | May 19, 1995 | SESE | | [K945167](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K945167.md) | DJ MEDICAL PNEUMATIC TOURNIQUET | Dj Medical, Inc. | Feb 13, 1995 | SESE | | [K942303](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K942303.md) | TECNADYNE T-CUFF | Technadyne Scientific, Inc. | Jul 20, 1994 | SESE | | [K933994](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K933994.md) | ARTHREX TOURNIQUET FOR LEG HOLDER | Arthrex, Inc. | Mar 23, 1994 | SESE | | [K925033](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K925033.md) | STILLE AUTOMATIC TOURNIQUET | Ferguson Medical | Feb 1, 1993 | SESE | | [K924273](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K924273.md) | ACCUFLATE | Instrumed, Inc. | Jan 12, 1993 | SESE | | [K910449](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K910449.md) | PRESTITCH | Crantec Co. | May 29, 1992 | SESE | | [K910512](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY/K910512.md) | ACCUFLATE | Instrumed, Inc. | Feb 19, 1991 | SESE | ## Top Applicants - Aspen Laboratories, Inc. — 5 clearances - Instrumed, Inc. — 5 clearances - Zimmer, Inc. — 2 clearances - Arthrex, Inc. — 1 clearance - Avec Scientific Design Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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