Karlson Ozone Sterilizer Model 100B

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K873200 ↗

FDA Product Code

FLF

Device Class

Class II

Regulation

21 CFR Part 880.6860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Thermoaire Splint (TAS)

  Class II

  FDA 510(k) K900356 Active Cleared 7 May 1990

• Mark VII Thermoregulation Assist System

  Class II

  FDA 510(k) K900355 Active Cleared 15 Feb 1990

• What types of medical devices can the Karlson Ozone Sterilizer Model 100B be used to sterilize?

  The Karlson Ozone Sterilizer Model 100B is designed for decontaminating reusable medical devices and instruments in general hospital settings. It uses ozone as the sterilizing agent, ensuring compliance with sterilization standards for equipment that requires reprocessing, such as surgical instruments, endoscopes, or other reusable hospital-grade items.

• Is the Karlson Ozone Sterilizer Model 100B intended for single-use or reusable applications?

  The device is explicitly designed as a reusable sterilization system. It is not intended for single-use applications, meaning it is meant to be used repeatedly in hospital environments for decontaminating reusable medical devices.

• How is the Karlson Ozone Sterilizer Model 100B regulated, and what does that mean for its use?

  The Karlson Ozone Sterilizer Model 100B is cleared by the FDA under a 510(k) pathway (K873200) and classified as a Class II device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets the requirements outlined in 21 CFR 880.6860, ensuring it is safe and effective for its intended use in hospital sterilization processes.

• What kind of sterilization process does the Karlson Ozone Sterilizer Model 100B use?

  The device employs ozone as the primary sterilizing agent, rather than traditional ethylene oxide gas. This method is intended to decontaminate reusable medical devices and instruments in compliance with hospital sterilization standards, providing an alternative sterilization approach for reprocessing equipment.