Ohio Unitrol II Anesthesia Gas Machine

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

510(k) Number

K840356 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ohio Absorber

  Class I

  FDA 510(k) K821144 Active Cleared 28 May 1982

• Ohio Disposable Tracheal Tube

  Class II

  FDA 510(k) K810763 Active Cleared 27 Mar 1981

• Ohio Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K822888 Active Cleared 16 Nov 1982

• Ohio 7000 Electronic Anesthesia Ventil.

  Class II

  FDA 510(k) K821376 Active Cleared 29 Jun 1982

• Ohio Free Flow Vacuum Regulator

  Class II

  FDA 510(k) K801169 Active Cleared 28 Jul 1980

• Non-Reusable Universal Nebulizer Filter

  Class II

  FDA 510(k) K823257 Active Cleared 9 Dec 1982

See all devices from Airco/Ohio Medical Products →

• Is the Ohio Unitrol II Anesthesia Gas Machine intended for single-use or reusable in clinical settings? Why does this matter?

  The Ohio Unitrol II is designed as a reusable medical device, meaning it must be properly cleaned, maintained, and serviced between uses according to the manufacturer’s guidelines and regulatory standards. This distinction matters because reusable devices require rigorous infection control protocols, calibration checks, and scheduled maintenance to ensure patient safety and device reliability over multiple procedures. Unlike single-use devices, reusable machines demand ongoing operational oversight to prevent malfunctions or contamination.

• What clinical environments is the Ohio Unitrol II Anesthesia Gas Machine approved for, and why are these settings relevant?

  The device is intended for use in operating rooms, recovery areas, and critical care settings where controlled administration of inhalation anesthetics is required. These environments are relevant because they involve high-risk procedures (e.g., surgery, sedation) where precise gas delivery, ventilation support, and emergency oxygen access are critical to patient outcomes. The design integrates features like flowmeters, vaporizers, and ventilators to meet these demands.

• How do I determine if a specific Ohio Unitrol II unit is compliant with FDA requirements, and what does the product code (BSZ) indicate?

  The Ohio Unitrol II holds an FDA 510(k) clearance (K840356) under the Anesthesiology advisory committee, classified under 21 CFR 868.5160 for anesthesia gas machines. The product code BSZ is an administrative identifier used by the FDA to categorize the device type (in this case, an anesthesia gas machine) for regulatory tracking. To verify compliance, check the unit’s serial number against the FDA’s OpenFDA database or consult the manufacturer’s documentation for maintenance records and clearance details.

• Does the Ohio Unitrol II include any built-in safety features for emergency oxygen delivery, and why is this important during anesthesia?

  Yes, the device incorporates an emergency oxygen supply system as part of its design. This feature is critical during anesthesia because it ensures a backup oxygen source in case of primary supply failure, hypoxia, or other emergencies. The integrated system helps maintain patient oxygenation until corrective action can be taken, reducing the risk of complications during procedures.

• Are there multiple models or configurations of the Ohio Unitrol II, and how might this affect my purchasing decision?

  The data lists multiple registration numbers (e.g., 3013188547, 3005783425) and FEI numbers, which suggest variations in model configurations or updates over time. These differences could relate to minor design changes, additional features, or compatibility with specific hospital systems. When purchasing, verify the exact model and its specifications against the manufacturer’s documentation to ensure it meets your facility’s workflow, ventilation requirements, and maintenance capabilities.