Panels › General, Plastic Surgery › Product code KCY · Class 1
Tourniquet, Pneumatic
Regulation 878.5910
0510(k)s in 12 months (34 all time)
70recalls in 12 months (112 all time)
7recalls that name a 510(k)
Top companies in KCY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN
Model/Catalog Number: 564015
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN
Model/Catalog Number: 564014
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE
Model/Catalog Number: 564013
Software Version: Not Applicable
Product Description: Sterile Disposable Tou Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE
Model/Catalog Number: 564012
Software Version: Not Applicable
Product Description: Sterile Disposable Tou Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE
Model/Catalog Number: 564011
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE
Model/Catalog Number: 564010
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW
Model/Catalog Number: 564009
Software Version: Not Applicable
Product Description: Sterile Disposable T Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW
Model/Catalog Number: 564008
Software Version: Not Applicable
Product Description: Sterile Disposable T Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED
Model/Catalog Number: 564007
Software Version: Not Applicable
Product Description: Sterile Disposable Tour Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED
Model/Catalog Number: 564006
Software Version: Not Applicable
Product Description: Sterile Disposable Tour Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY
Model/Catalog Number: 564005
Software Version: Not Applicable
Product Description: Sterile Disposable Tou Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM
Model/Catalog Number: 564003
Software Version: Not Applicable
Product Description: Sterile Disposable T Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10)
Model/Catalog Number: 564001
Software Version: Not Applicable
Product Description: Sterile Disposable Tourniq Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE
Model/Catalog Number: 553323
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Oct 1, 2026 | ASP Global, LLC. Brand Name: Expressaire
Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE
Model/Catalog Number: 553322
Software Version: Not Applicable
Product Description: Sterile Disposable To Open, Classified |
KCY | None listed |
| Jul 2, 2026 | Zimmer Surgical Inc Brand Name: Sterile Tourniquet Hoses
Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors
Model/Catalog Number: 60-4009-101-00
Software Version: N/A
Product Description: Sing Open, Classified |
KCY | None listed |
| Jul 2, 2026 | Zimmer Surgical Inc Brand Name: Sterile Tourniquet Hoses
Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors
Model/Catalog Number: 60-1812-101-00
Software Version: N/A
Product Description: Dual S Open, Classified |
KCY | None listed |
| Apr 9, 2026 | Stryker Sustainability Solutions Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235
Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bl Open, Classified |
KCY | None listed |
| Jan 28, 2026 | Zimmer Surgical Inc Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S. 3200TS Tourniquet Systems
Model/Catalog Number: 60320010100
Software Version: Software version v2.06 or prior are within scope of the recall Open, Classified |
KCY | K050411 |
| Jan 28, 2026 | Zimmer Surgical Inc Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S. 5000TS Tourniquet Systems
Model/Catalog Number: 60500010100
Software Version: Software version v2.04 or prior are within scope of the recall Open, Classified |
KCY | K202919 |
| Aug 7, 2025 | Stryker Corporation Stryker SmartPump Tourniquet, disposable sterile (single use)
DISP 18X3,1BLA,1PRT
QUICK / 5921-018-135;
DISP 18X3,1BLA,2PRT
QUICK / 5921-018-235;
DISP 24X4,1BLA, 2PRT
QUICK / 5921-024-235 Open, Classified |
KCY | None listed |
| Jul 17, 2024 | Stryker Sustainability Solutions REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK
Catalog number: 5921-218-235NS
Indicated for use in surgical procedures that require the temporary occlusion of Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK
Catalog number: 5921-218-135NS Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK
Catalog number: 5921-034-235NS
Indicated for use in surgical procedures that require the temporary occlusion of Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK
Catalog number: 5921-034-135NS
Indicated for use in surgical procedures that require the temporary occlusion of Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK
Catalog number: 5921-030-235NS
Indicated for use in surgical procedures that require the temporary occlusion of Open, Classified |
KCY | None listed |
| Apr 4, 2023 | Stryker Corporation Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK
Catalog number: 5921-030-135NS
Indicated for use in surgical procedures that require the temporary occlusion of Open, Classified |
KCY | None listed |
| Apr 1, 2023 | Stryker Sustainability Solutions Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135;
Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235;
Color Open, Classified |
KCY | None listed |
| Jan 21, 2022 | Stryker Sustainability Solutions REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder Terminated |
KCY | None listed |
| Jan 28, 2020 | Zimmer Surgical Inc Zimmer Sterile Disposable
Tourniquet Cuff with Protective
Sleeve and PLC, Dual Port, Dual
Bladder, Item No. 60708015200, UDI (01)00889024377547
(17)230812(10)27968701
The product is a tourniquet - Pr Terminated |
KCY | None listed |
| Nov 6, 2019 | Stryker Instruments Div. of Stryker Corporation Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Terminated |
KCY | None listed |
| Nov 6, 2019 | Stryker Instruments Div. of Stryker Corporation Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tournique Terminated |
KCY | None listed |
| Oct 9, 2019 | Stryker Sustainability Solutions Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated Terminated |
KCY | None listed |
| Apr 3, 2019 | Delfi Medical Innovations, Inc. DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE
Rx Only, Sterile Terminated |
KCY | None listed |
| Apr 3, 2019 | Delfi Medical Innovations, Inc. Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003.
Rx Only, Sterile Terminated |
KCY | None listed |
| Jul 27, 2017 | Zimmer Surgical Inc A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622
Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extrem Terminated |
KCY | None listed |
| Jul 27, 2017 | Zimmer Surgical Inc A.T.S. 4000TS Tourniquet Systems, Personalized Pressure.
Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on tho Terminated |
KCY | K123553 |
| Sep 19, 2016 | Stryker Sustainability Solutions Reprocessed Pressure Tourniquet Cuff (PTC)
Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, Terminated |
KCY | None listed |
| Jan 12, 2016 | Stryker Sustainability Solutions Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs
Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236
Indicated for use in patients who require Terminated |
KCY | None listed |
| Nov 13, 2015 | STERILMED, INC. Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only. Terminated |
KCY | None listed |
| Sep 28, 2015 | STERILMED, INC. Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed.
Products are individually packaged Terminated |
KCY | None listed |
| Aug 6, 2015 | Zimmer Surgical Inc 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arter Terminated |
KCY | None listed |
| Aug 6, 2015 | Zimmer Surgical Inc 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood Terminated |
KCY | None listed |
| Jan 6, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker Color Cuff, REF 5921-034-135
Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm)
Single Bladder, Single Port, QuickConnect
Rx only, STERILE Terminated |
KCY | None listed |
| Nov 15, 2012 | Zimmer, Inc. ATS 3000 Automatic Tourniquet System
w/HOSES AND LOP SENSOR
Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical proced Terminated |
KCY | None listed |
| Sep 21, 2011 | Stryker Instruments Div. of Stryker Corporation Stryker SmartPump Extension Tubing (Pneumatic tourniquet).
Sterile tubing extension 40" and 60", set, luer lock. Rx only.
Stryker Instruments Div. of Stryker Corporation.
Optional accessories used wi Terminated |
KCY | K952038 |
| Jan 18, 2011 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments, SmartPump Tourniquet System, Report Printer Kit, REF 5920-012-000, Rx only, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210.
Provides a record of a Terminated |
KCY | K924273 |
| Jan 18, 2011 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet Pump, REF 5920-010-000, Rx only, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210.
Intended t Terminated |
KCY | K924273 |
| Jan 18, 2011 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF 5920-011-000, Rx only.
Intended to be used to temporarily occlude or decrease blood flow in a patient extremity duri Terminated |
KCY | K924273 |
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