Identifiers
- 510(k) Number
- K873614 FDA 510(k)
- FDA Product Code
- BSK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5750 FDA 510(k)
- Regulation Number
- 868.5750 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A cuff, tracheal tube, inflatable device used to measure pressure in tracheal tube cuffs. It is classified as a Class II medical device under regulation number 868.5750.
The device is supplied non-sterile and intended for reusable use. It is indicated for use in anesthesiology settings and has received FDA 510(k) clearance under K873614.
Frequently asked questions
What is the CBG CUFF MANOMETER used for?
The CBG CUFF MANOMETER is used to measure pressure in tracheal tube cuffs, helping clinicians monitor and maintain appropriate cuff inflation during anesthesia to prevent complications such as tracheal mucosal injury or aspiration.
Is the CBG CUFF MANOMETER sterile or non-sterile, and is it intended for single-use or reusable applications?
The CBG CUFF MANOMETER is supplied non-sterile and is intended for reusable use, meaning it can be cleaned and reprocessed for multiple patient uses according to the manufacturer's instructions.
In which clinical setting is the CBG CUFF MANOMETER indicated for use?
The CBG CUFF MANOMETER is indicated for use in anesthesiology settings, where it supports the management of endotracheal or tracheal tube cuff pressure during surgical procedures requiring mechanical ventilation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CBG CUFF MANOMETER (K873614) — FDA 510 (k) | Innolitics, CBG CUFF MANOMETER 510 (k) K873614 - FDA.report, Bio-Med Devices - Ventilators, Blenders & Respiratory Care, BIO-MED DEVICES, INC. FDA Filings - FDA.report, Bio-Med Devices… — 14 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K873614 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Med Devices, Inc.
Sources (1)
- FDA 510(k) K873614 24 fields · synced Oct 1, 2026