AG Guffill
510(k) K122721
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122721 | Date3 May 2013 | StatusActive |
Official records
- FDA 510(k) database K122721
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSK
- FDA applicant
- Hospitech Respiration , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5750
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The AG Cuffill is an Inflatable Tracheal Tube Cuff, designed to measure and regulate intra-cuff pressure in endotracheal tubes, tracheotomy tubes, and laryngeal mask airways (LMAs). It ensures proper cuff inflation to maintain airway patency and reduce the risk of complications such as tracheal injury or aspiration during mechanical ventilation.
This device is intended for use in clinical settings such as hospitals, pre-hospital (EMS), and extended care facilities under medical supervision. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K122721) and falls under the Anesthesiology advisory committee classification. Multiple registration and FEI numbers (e.g., 3016548968, 3007048256) correspond to its various model variants, all adhering to regulation 868.5750.
Devices cleared under K122721
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AG Cuffill (cmH2O) HSCUFF0041 | HSCUFF0041 / HSCUFF0041 | 07290015409001 | On the market | |
| AG Cuffill (mmHg) HSCUFF0031 | HSCUFF0031 / HSCUFF0031 | 07290015409032 | On the market | |
| AG Cuffill Kruuse - VET | HSCUFF0052 / AG Cuffill Kruuse - VET | 07290015409018 | On the market |
Similar devices
Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).
- ATTACHABLE LANZ (TENTATIVE) by Mallinckroot, Inc.
- PRESSURE GAUGE by Innovations For Mechanical Ventilation, Inc.
- TRACOE smart Cuff Manager by Tracoe medical GmbH
- TrachFlush by Aw Technologies Aps
- PYTON by Arm Medical Devices, Inc.
- PILOT TUBE REPAIR KIT by Instrumentation Industries, Inc.
- Puritan Bennett 180-05 by Covidien LP
- CBG Cuff Manometer by Bio-Med Devices, Inc.
- Medis AC0100P by Tianjin Medis Medical Device Co., Ltd.
- Puritan Bennett 180-03 by Covidien LP