Cuff-Cath

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935090 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Ohmeda Medical →

• What is the Cuff-Cath designed for in healthcare settings?

  The Cuff-Cath is a gas outlet fitting specifically engineered to connect medical gas supply lines to patient circuits or equipment. Its cuffed design ensures a secure, leak-proof connection, which is critical for delivering gases like oxygen, nitrous oxide, or anesthesia agents safely and without interruption. This prevents contamination or air ingress, maintaining the integrity of the gas flow.

• How is the Cuff-Cath supplied and intended for use?

  The Cuff-Cath is supplied as a reusable component, intended for permanent installation in hospital infrastructure such as walls, ceilings, or consoles. It is designed to integrate into existing medical gas systems, ensuring compatibility with standardized fittings like Ohmeda (Diamond), Chemetron, and DISS. Facilities must follow manufacturer guidelines for proper installation and maintenance to ensure functionality and safety.

• Is the Cuff-Cath single-use or reusable, and what does that mean for its care?

  The Cuff-Cath is not designated as single-use; it is intended for reuse. As a reusable device, it must be cleaned and maintained according to manufacturer instructions to prevent contamination and ensure reliable performance. Proper care includes regular inspections and adherence to facility protocols for gas outlet fittings to avoid leaks or malfunctions.

• What standards does the Cuff-Cath comply with for compatibility?

  The Cuff-Cath is compatible with multiple industry-standard gas outlet fittings, including Ohmeda (Diamond), Chemetron, and DISS (Diameter Index Safety System) standards. This ensures it can be seamlessly integrated into various hospital gas delivery systems, reducing the risk of misconnections and ensuring safe operation across different medical environments.

• How is the Cuff-Cath regulated, and what does that mean for its use?

  The Cuff-Cath holds FDA 510(k) clearance (K935090) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This regulatory clearance confirms it meets U.S. safety and performance standards for gas outlet fittings in general hospital settings. Hospitals may rely on this clearance to ensure compliance with healthcare regulations when installing and using the device.