Disposable Color-Cuffs
FDA 510(k) K890014 · Instrumed, Inc.
510(k) numberK890014
Submission
- Device name
- Disposable Color-Cuffs
- Applicant
- Instrumed, Inc.
Kirkland, WA, US - Received
- January 3, 1989
- Decision date
- January 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KCY – Tourniquet, Pneumatic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.5910
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KCY
| 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 |
More from Scandinavian Medical JW AB
| 510(k) | Device | Decision |
|---|---|---|
| K952038 | Clean-CuffKCY · Traditional | 07/11/1995SE |
| K940615 | AccutestKCY · Traditional | 05/19/1995SE |
| K924273 | AccuflateKCY · Traditional | 01/12/1993SE |
| K924373 | Accuflate Accessorie Cart W/Iv Pole and ClampBZN · Traditional | 11/25/1992SE |
| K910512 | AccuflateKCY · Traditional | 02/19/1991SE |
| K860617 | PolypetJTC · Traditional | 03/03/1986SE |
Questions and answers
When was Disposable Color-Cuffs cleared by the FDA?
Disposable Color-Cuffs (K890014) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 21 days after the submission was received.
What is the product code of K890014?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.