KCY · Tourniquet, Pneumatic
General, Plastic Surgery · 21 CFR 878.5910 · Class 1
Overview
| Product Code | KCY |
|---|---|
| Device Name | Tourniquet, Pneumatic |
| Regulation | 21 CFR 878.5910 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | May 20, 2021 | SESE |
| K162365 | T-Cuff | Terumobct, Inc. | Feb 16, 2017 | SESE |
| K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | Aug 9, 2013 | SESE |
| K112874 | EZ VEIN INFLATABLE TOURNIQUET | Dominion Medical Devices, LLC | Oct 17, 2011 | SESE |
| K071140 | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | Top Spins, Inc. | Jun 7, 2007 | SESE |
| K050411 | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | Sep 2, 2005 | SESE |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | Oct 26, 2001 | SESE |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | Jan 5, 1996 | SESE |
| K954201 | BUONAFEDE PNEUMATIC SLEEVE | Promedic, Inc. | Nov 9, 1995 | SESE |
| K954103 | TOURNI-COMP | Scandinavian Medical JW AB | Nov 1, 1995 | SESE |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | Sep 29, 1995 | SESE |
| K952038 | CLEAN-CUFF | Instrumed, Inc. | Jul 11, 1995 | SESE |
| K940615 | ACCUTEST | Instrumed, Inc. | May 19, 1995 | SESE |
| K945167 | DJ MEDICAL PNEUMATIC TOURNIQUET | Dj Medical, Inc. | Feb 13, 1995 | SESE |
| K942303 | TECNADYNE T-CUFF | Technadyne Scientific, Inc. | Jul 20, 1994 | SESE |
| K933994 | ARTHREX TOURNIQUET FOR LEG HOLDER | Arthrex, Inc. | Mar 23, 1994 | SESE |
| K925033 | STILLE AUTOMATIC TOURNIQUET | Ferguson Medical | Feb 1, 1993 | SESE |
| K924273 | ACCUFLATE | Instrumed, Inc. | Jan 12, 1993 | SESE |
| K910449 | PRESTITCH | Crantec Co. | May 29, 1992 | SESE |
| K910512 | ACCUFLATE | Instrumed, Inc. | Feb 19, 1991 | SESE |
Top Applicants
- Instrumed, Inc. — 5 clearances
- Aspen Laboratories, Inc. — 5 clearances
- Zimmer, Inc. — 2 clearances
- Woodville Polymer Engineering, Ltd. — 1 clearance
- Top Spins, Inc. — 1 clearance
