RASCAL II

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

510(k) Number

K920622 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ohmeda Medical →

• What clinical settings is the RASCAL II designed for, and how does it contribute to patient safety during procedures?

  The RASCAL II is specifically designed for use in clinical settings like operating rooms and intensive care units, where real-time monitoring of respiratory and anesthetic gases is critical. It measures carbon dioxide levels in exhaled gases, providing immediate feedback to clinicians. This helps ensure patient safety by allowing adjustments to ventilation and anesthesia parameters based on accurate, up-to-date data during procedures.

• Is the RASCAL II a single-use or reusable device, and what maintenance does it require?

  The RASCAL II is a reusable medical instrument, not intended for single-use. Like all reusable devices, it requires proper calibration and regular maintenance as outlined by the manufacturer to ensure accurate performance. Facilities must follow both regulatory guidelines and their own protocols for cleaning, sterilization, and upkeep to maintain reliability.

• How was the RASCAL II evaluated by the FDA, and what does its classification under product code CCK indicate?

  The RASCAL II underwent a traditional FDA review process and was granted 510(k) clearance, demonstrating it is *substantially equivalent* to a legally marketed device in its category. Its classification under product code CCK (Anesthesiology) reflects its role in monitoring respiratory and anesthetic gases, ensuring compliance with FDA standards for devices used in anesthesia-related procedures.

• Who is the manufacturer, and where can I contact them for support or maintenance inquiries?

  The manufacturer of the RASCAL II is Ohmeda Medical, now part of a larger medical technology company. For support, maintenance, or technical inquiries, you can contact Dwight Hibdon at the address 4745 Wiley Post Way, Suite 650, Salt Lake City, UT 84116, USA. Always verify current contact details through official manufacturer channels, as ownership or contact information may have changed.