Cuffalert
FDA 510(k) K081805 · Sunmed
510(k) numberK081805
Submission
- Device name
- Cuffalert
- Applicant
- Sunmed
Bonita Springs, FL, US - Received
- June 26, 2008
- Decision date
- November 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K220854 | TrachCuff Cuff ControllerBSK · Traditional | Aw Technologies Aps | 04/14/2023SE |
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| K202874 | Puritan Bennett Cuff Pressure ManagerBSK · Traditional | Covidien, LLC | 01/09/2021SE |
| K192611 | CuffixBSK · Traditional | Biovo Technologies , Ltd. | 08/13/2020SE |
| K191858 | Pylant MonitorBSK · Traditional | Kal-Med, LLC | 02/24/2020SE |
| K182548 | Accucuff Cuff Pressure IndicatorBSK · Traditional | Tianjin Medis Medical Device Co., Ltd. | 01/25/2019SE |
| K180991 | AG 100sBSK · Traditional | Hospitech Respiration , Ltd. | 10/12/2018SE |
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| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | 02/27/1996SE |
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Questions and answers
When was Cuffalert cleared by the FDA?
Cuffalert (K081805) received a 510(k) decision of Substantially Equivalent on November 14, 2008, 141 days after the submission was received.
What is the product code of K081805?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.