Product code KCY
- Device name
- Tourniquet, Pneumatic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.5910
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | 2021-05-20 |
| K162365 | T-Cuff | Terumobct, Inc. | 2017-02-16 |
| K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2013-08-09 |
| K112874 | EZ VEIN INFLATABLE TOURNIQUET | Dominion Medical Devices, LLC | 2011-10-17 |
| K071140 | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | Top Spins, Inc. | 2007-06-07 |
| K050411 | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2005-09-02 |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | 2001-10-26 |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | 1996-01-05 |
| K954201 | BUONAFEDE PNEUMATIC SLEEVE | Promedic, Inc. | 1995-11-09 |
| K954103 | TOURNI-COMP | Scandinavian Medical JW AB | 1995-11-01 |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | 1995-09-29 |
| K952038 | CLEAN-CUFF | Instrumed, Inc. | 1995-07-11 |
| K940615 | ACCUTEST | Instrumed, Inc. | 1995-05-19 |
| K945167 | DJ MEDICAL PNEUMATIC TOURNIQUET | Dj Medical, Inc. | 1995-02-13 |
| K942303 | TECNADYNE T-CUFF | Technadyne Scientific, Inc. | 1994-07-20 |
| K933994 | ARTHREX TOURNIQUET FOR LEG HOLDER | Arthrex, Inc. | 1994-03-23 |
| K925033 | STILLE AUTOMATIC TOURNIQUET | Ferguson Medical | 1993-02-01 |
| K924273 | ACCUFLATE | Instrumed, Inc. | 1993-01-12 |
| K910449 | PRESTITCH | Crantec Co. | 1992-05-29 |
| K910512 | ACCUFLATE | Instrumed, Inc. | 1991-02-19 |
| K900104 | TCPM II TOURNIQUET CUFF PRESSURE MONITOR | Electromedics, Inc. | 1990-03-15 |
| K890014 | DISPOSABLE COLOR-CUFFS | Instrumed, Inc. | 1989-01-24 |
| K880020 | 3 IN 1 AUTOMATIC TOURNIQUET | Systematics Mfg. & Tool Co., Inc. | 1988-03-17 |
| K871982 | TOURNIQUET PRESSURE REGULATOR | Avec Scientific Design Corp. | 1987-06-09 |
| K870784 | A.T.S. 1500 TOURNIQUET | Aspen Laboratories, Inc. | 1987-03-18 |
| K860463 | SINGLE AND DUAL TOURNIQUET CUFF | Aspen Laboratories, Inc. | 1986-02-25 |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | Orthofab, Inc. | 1986-01-24 |
| K853802 | ATS 500 TOURNIQUET | Aspen Laboratories, Inc. | 1985-10-07 |
| K842963 | RHYS-DAVIES EXSANGUINATOR | Woodville Polymer Engineering, Ltd. | 1984-08-17 |
| K841558 | BANANA CUFF | Aspen Laboratories, Inc. | 1984-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613154599318 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599462 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599455 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599448 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599431 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599424 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599417 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599394 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599387 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599370 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599363 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599356 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599349 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599332 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599325 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599301 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599295 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599288 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599271 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599264 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154599257 | Color Cuff | STRYKER CORPORATION | 2018-09-24 |
| 07613154598984 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599066 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599059 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599042 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599035 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599028 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599011 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154599004 | NA | STRYKER CORPORATION | 2017-09-22 |
| 07613154598991 | NA | STRYKER CORPORATION | 2017-09-22 |