Accucuff Cuff Pressure Indicator
FDA 510(k) K182548 · Tianjin Medis Medical Device Co., Ltd.
510(k) numberK182548
Submission
- Device name
- Accucuff Cuff Pressure Indicator
- Applicant
- Tianjin Medis Medical Device Co., Ltd.
Tainjin, CN - Received
- September 17, 2018
- Decision date
- January 25, 2019
- 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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|---|---|---|---|
| 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 |
| K180991 | AG 100sBSK · Traditional | Hospitech Respiration , Ltd. | 10/12/2018SE |
| K173914 | VORTRAN Cuff Inflator (VCI)BSK · Traditional | Vortran Medical Technology 1, Inc. | 05/25/2018SE |
More from Vortran Medical Technology 1, Inc.
Questions and answers
When was Accucuff Cuff Pressure Indicator cleared by the FDA?
Accucuff Cuff Pressure Indicator (K182548) received a 510(k) decision of Substantially Equivalent on January 25, 2019, 130 days after the submission was received.
What is the product code of K182548?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.