Buonafede Pneumatic Sleeve
FDA 510(k) K954201 · Promedic, Inc.
510(k) numberK954201
Submission
- Device name
- Buonafede Pneumatic Sleeve
- Applicant
- Promedic, Inc.
Sturgis, MI, US - Received
- September 6, 1995
- Decision date
- November 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Deroyal Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131889 | Eum 100PROOSP · Traditional | 04/23/2014SE |
| K112318 | Clearpath 24OCX · Traditional | 06/29/2012SE |
| K072756 | Non-Iv Adapter for Infant NG TubeKNT · Traditional | 12/19/2007SESK |
| K060497 | BabyairCAF · Traditional | 07/11/2006SE |
| K060842 | Revjet TurboCAF · Traditional | 06/21/2006SE |
| K052903 | Pediatric Feeding TubeKNT · Traditional | 11/09/2005SE |
| K031409 | Urinary CathetersGBM · Traditional | 06/17/2003SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | 03/17/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
| K020005 | Infant Feeding TubesKNT · Traditional | 07/16/2002SE |
Questions and answers
When was Buonafede Pneumatic Sleeve cleared by the FDA?
Buonafede Pneumatic Sleeve (K954201) received a 510(k) decision of Substantially Equivalent on November 9, 1995, 64 days after the submission was received.
What is the product code of K954201?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.