Cuff Baro Guard or CBG Abbreviated
FDA 510(k) K901255 · Nelson Engineering, Inc.
510(k) numberK901255
Submission
- Device name
- Cuff Baro Guard or CBG Abbreviated
- Applicant
- Nelson Engineering, Inc.
Guilford, CT, US - Received
- March 15, 1990
- Decision date
- March 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code BSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261499 | TrachFlushBSK · Traditional | Aw Technologies Aps | 08/13/2026SE |
| K243562 | CuffGuardBSK · Traditional | Idmed | 08/12/2025SE |
| K242642 | CuffTrekBSK · Traditional | Shanghai Longmann Tech Co., Ltd. | 03/07/2025SE |
| K220854 | TrachCuff Cuff ControllerBSK · Traditional | Aw Technologies Aps | 04/14/2023SE |
| K221477 | AG100sBSK · Traditional | Hospitech Respiration , Ltd. | 12/29/2022SE |
| 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 |
Questions and answers
When was Cuff Baro Guard or CBG Abbreviated cleared by the FDA?
Cuff Baro Guard or CBG Abbreviated (K901255) received a 510(k) decision of Substantially Equivalent on March 28, 1990, 13 days after the submission was received.
What is the product code of K901255?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.