Vaplok

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

510(k) Number

K864605 ↗

FDA Product Code

CAD

Device Class

Class II

Regulation

21 CFR Part 868.5880

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bear 7 Ventilator

  Class II

  FDA 510(k) K912619 Active Cleared 11 Jun 1992

• Bear Jet-150 Ventilator

  Class II

  FDA 510(k) K842688 Active Cleared 26 Jul 1984

• Tri-Service Omv Vaporizer

  Class II

  FDA 510(k) K864589 Active Cleared 5 Jun 1987

• VHS 820 Humidifier

  Class II

  FDA 510(k) K893034 Active Cleared 14 Jul 1989

• Bear Nvm-1

  Class II

  FDA 510(k) K872660 Active Cleared 12 Feb 1988

• VH820 Humidifier

  Class II

  FDA 510(k) K842340 Active Cleared 17 Jul 1984

See all devices from Bear Medical Systems, Inc. →

• What types of anesthetic agents can the Vaplok deliver, and how does it ensure precise dosing during surgery?

  The Vaplok is designed specifically for delivering volatile anesthetic agents used in inhalation anesthesia. It ensures precise concentration control by maintaining consistent vaporization without heating, which is critical for safe and effective anesthesia delivery during surgical procedures. This design helps anesthesiologists adjust and maintain the exact dosage required for each patient.

• Is the Vaplok intended for single-use or reusable applications in clinical settings?

  The Vaplok is supplied as a reusable medical instrument, meaning it is meant for repeated use in operating rooms and anesthesia care settings. Unlike single-use devices, it requires proper cleaning, maintenance, and sterilization protocols between uses to ensure safety and functionality.

• How is the Vaplok regulated by the FDA, and what does this mean for clinicians using the device?

  The Vaplok is regulated under the FDA’s 510(k) clearance process (K864605) as a Class 2 device with product code CAD, indicating it is substantially equivalent to a legally marketed predicate device. This classification means it undergoes traditional review standards, ensuring compliance with safety and performance requirements for anesthesia vaporizers. Clinicians can rely on its regulatory pathway as evidence of its intended use in controlled anesthesia delivery.

• Are there any special storage requirements for the Vaplok when it is not in use?

  The provided data does not specify any special storage conditions (e.g., temperature, humidity, or protection from contamination) for the Vaplok. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or sources of physical damage to maintain its integrity and functionality for future use.