Tourniquet, Pneumatic
FDA product code KCY · Class I (low risk) · 21 CFR 878.5910 · General, Plastic Surgery
34510(k) clearances
0PMA approvals
42recalls
Manufacturers
- Aspen Laboratories, Inc. 5
- Instrumed, Inc. 5
- Zimmer, Inc. 2
- Crantec Co. 1
- Mcewen and Associates Consulting , Ltd. 1
- Smith & Nephew Richards, Inc. 1
- Promedic, Inc. 1
- Scandinavian Medical JW AB 1
- DeRoyal Industries Inc 1
- Dj Medical, Inc. 1
- Technadyne Scientific, Inc. 1
- Arthrex, Inc. 1
- Ferguson Medical 1
- Nestor Engineering Associates, Inc. 1
- Electromedics, Inc. 1
- Systematics Mfg. & Tool Co., Inc. 1
- Avec Scientific Design Corp. 1
- Orthofab, Inc. 1
- Woodville Polymer Engineering, Ltd. 1
- Richards Medical Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet InstrumentKCY · Traditional | Mcewen and Associates Consulting , Ltd. | 05/20/2021SE |
| K162365 | T-CuffKCY · Traditional | Terumobct, Inc. | 02/16/2017SE |
| K123553 | Zimmer A.T.S. 4000TS Automatic Tourniquet SystemKCY · Traditional | Zimmer, Inc. | 08/09/2013SE |
| K112874 | Ez Vein Inflatable TourniquetKCY · Traditional | Dominion Medical Devices, LLC | 10/17/2011SE |
| K071140 | MRI Compatible Thigh Tourniquet, Model C070002KCY · Traditional | Top Spins, Inc. | 06/07/2007SE |
| K050411 | Zimmer A.T.S. 3000 Automatic Tourniquet SystemKCY · Traditional | Zimmer, Inc. | 09/02/2005SE |
| K012632 | Tourniquet Cuff; Pneumatic TourniquetKCY · Traditional | Medical Instruments Technology, Inc. | 10/26/2001SE |
| K955552 | Expressaire Toruniquet SystemKCY · Traditional | Smith & Nephew Richards, Inc. | 01/05/1996SE |
| K954201 | Buonafede Pneumatic SleeveKCY · Traditional | Promedic, Inc. | 11/09/1995SE |
| K954103 | Tourni-CompKCY · Traditional | Scandinavian Medical JW AB | 11/01/1995SE |
| K953953 | Deroyal Industries, Inc. Pneumatic Tourniquet CuffKCY · Traditional | Deroyal Industries, Inc. | 09/29/1995SE |
| K952038 | Clean-CuffKCY · Traditional | Instrumed, Inc. | 07/11/1995SE |
| K940615 | AccutestKCY · Traditional | Instrumed, Inc. | 05/19/1995SE |
| K945167 | DJ Medical Pneumatic TourniquetKCY · Traditional | Dj Medical, Inc. | 02/13/1995SE |
| K942303 | Tecnadyne T-CuffKCY · Traditional | Technadyne Scientific, Inc. | 07/20/1994SE |
| K933994 | Arthrex Tourniquet for Leg HolderKCY · Traditional | Arthrex, Inc. | 03/23/1994SE |
| K925033 | Stille Automatic TourniquetKCY · Traditional | Ferguson Medical | 02/01/1993SE |
| K924273 | AccuflateKCY · Traditional | Instrumed, Inc. | 01/12/1993SE |
| K910449 | PrestitchKCY · Traditional | Crantec Co. | 05/29/1992SE |
| K910512 | AccuflateKCY · Traditional | Instrumed, Inc. | 02/19/1991SE |
| K900104 | TCPM II Tourniquet Cuff Pressure MonitorKCY · Traditional | Electromedics, Inc. | 03/15/1990SE |
| K890014 | Disposable Color-CuffsKCY · Traditional | Instrumed, Inc. | 01/24/1989SE |
| K880020 | 3 in 1 Automatic TourniquetKCY · Traditional | Systematics Mfg. & Tool Co., Inc. | 03/17/1988SE |
| K871982 | Tourniquet Pressure RegulatorKCY · Traditional | Avec Scientific Design Corp. | 06/09/1987SE |
| K870784 | A.T.S. 1500 TourniquetKCY · Traditional | Aspen Laboratories, Inc. | 03/18/1987SE |
| K860463 | Single and Dual Tourniquet CuffKCY · Traditional | Aspen Laboratories, Inc. | 02/25/1986SE |
| K860095 | Digikit Nonpneumatic TourniquetKCY · Traditional | Orthofab, Inc. | 01/24/1986SE |
| K853802 | Ats 500 TourniquetKCY · Traditional | Aspen Laboratories, Inc. | 10/07/1985SE |
| K842963 | Rhys-Davies ExsanguinatorKCY · Traditional | Woodville Polymer Engineering, Ltd. | 08/17/1984SE |
| K841558 | Banana CuffKCY · Traditional | Aspen Laboratories, Inc. | 07/16/1984SE |
| K840206 | Pressure Sentry TourniquetKCY · Traditional | Richards Medical Co., Inc. | 04/25/1984SE |
| K813231 | TourniquetKCY · Traditional | Aspen Laboratories, Inc. | 12/14/1981SE |
| K791759 | Test Pressure Gauge #6675-32KCY · Traditional | Depuy, Inc. | 10/04/1979SE |
| K780988 | Devin-Nestor Pneumatic TourniquetKCY · Traditional | Nestor Engineering Associates, Inc. | 10/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2674-2026 Class II | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems…Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized… | Zimmer Surgical Inc | 06/09/2026Open, Classified |
| Z-2673-2026 Class II | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual…Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized… | Zimmer Surgical Inc | 06/09/2026Open, Classified |
| Z-1804-2026 Class II | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the… | Stryker Sustainability Solutions | 03/12/2026Open, Classified |
| Z-1202-2026 Class II | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 3200TS Tourniquet Systems…Device user interface (screen) may freeze or become unresponsive to touch when operating in certain… | Zimmer Surgical Inc | 12/24/2025Open, Classified |
| Z-1201-2026 Class II | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems…Device user interface (screen) may freeze or become unresponsive to touch when operating in certain… | Zimmer Surgical Inc | 12/24/2025Open, Classified |
| Z-2277-2025 Class II | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK…Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may… | Stryker Corporation | 07/02/2025Open, Classified |
| Z-2405-2024 Class II | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single…Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff… | Stryker Sustainability Solutions | 05/31/2024Open, Classified |
| Z-1344-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1343-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1342-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1341-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1340-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1339-2023 Class II | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK…Not able to achieve desired pressure and not holding pressure result from two different causes which have… | Stryker Corporation | 03/01/2023Open, Classified |
| Z-1315-2023 Class II | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135…Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding… | Stryker Sustainability Solutions | 03/01/2023Open, Classified |
| Z-0664-2022 Class II | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single…Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | Stryker Sustainability Solutions | 01/21/2022Terminated |
| Z-1356-2020 Class II | Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port…When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak… | Zimmer Surgical Inc | 01/03/2020Terminated |
| Z-0593-2020 Class II | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder)…There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | Stryker Instruments Div. of Stryker… | 11/06/2019Terminated |
| Z-0592-2020 Class II | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder)…There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | Stryker Instruments Div. of Stryker… | 11/06/2019Terminated |
| Z-1802-2020 Class II | Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number:…Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2)… | Stryker Sustainability Solutions | 10/09/2019Terminated |
| Z-1902-2020 Class II | DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF…Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile… | Delfi Medical Innovations, Inc. | 04/03/2019Terminated |
| Z-1901-2020 Class II | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single…Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile… | Delfi Medical Innovations, Inc. | 04/03/2019Terminated |
| Z-0613-2018 Class II | A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH…Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters… | Zimmer Surgical Inc | 07/27/2017Terminated |
| Z-0612-2018 Class II | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by…Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters… | Zimmer Surgical Inc | 07/27/2017Terminated |
| Z-0324-2017 Class II | Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder…Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may… | Stryker Sustainability Solutions | 09/19/2016Terminated |
| Z-0629-2016 Class II | Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers:…Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when… | Stryker Sustainability Solutions | 12/17/2015Terminated |
| Z-0404-2016 Class II | Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed…Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure… | Sterilmed, Inc. | 11/13/2015Terminated |
| Z-2819-2015 Class II | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC)…Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number… | Sterilmed, Inc. | 08/24/2015Terminated |
| Z-2349-2015 Class II | 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical…The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. | Zimmer Surgical Inc | 06/24/2015Terminated |
| Z-2348-2015 Class II | 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc.…The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. | Zimmer Surgical Inc | 06/24/2015Terminated |
| Z-0630-2014 Class II | Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x…The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect… | Stryker Instruments Div. of Stryker… | 12/06/2013Terminated |
| Z-0296-2013 Class II | ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by…Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints… | Zimmer, Inc. | 09/05/2012Terminated |
| Z-3274-2011 | Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40"…Three complaints have been reported indicating that the product inside the package did not match the label… | Stryker Instruments Div. of Stryker… | 08/25/2011Terminated |
| Z-0914-2011 | Stryker Instruments, SmartPump Tourniquet System, Report Printer Kit, REF 5920-012-000…This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the… | Stryker Instruments Div. of Stryker… | 04/13/2010Terminated |
| Z-0913-2011 | Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet Pump, REF…This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the… | Stryker Instruments Div. of Stryker… | 04/13/2010Terminated |
| Z-0912-2011 | Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF…This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the… | Stryker Instruments Div. of Stryker… | 04/13/2010Terminated |
| Z-0908-2009 | Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for…The inflation tube may come loose at the connection to the cuff during use. | Virtus, Inc. | 11/24/2008Terminated |
| Z-0907-2009 | Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for…The inflation tube may come loose at the connection to the cuff during use. | Virtus, Inc. | 11/24/2008Terminated |
| Z-0572-2009 | Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |
| Z-1679-2008 | Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic tourniquet.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-1678-2008 | Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-1673-2008 | Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile device -- Pneumatic…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-1662-2008 | Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock Connector Brown Trim…Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |