Ohmeda 5410 Volume Monitor

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

510(k) Number

K862687 ↗

FDA Product Code

BZK

Device Class

Class II

Regulation

21 CFR Part 868.1850

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

• Ohmeda Medical Omnibed

  Class II

  FDA 510(k) K993407 Active Cleared 5 Jan 2000

• Ohmeda 7900 Anesthesia Ventilator

  Class II

  FDA 510(k) K960964 Active Cleared 27 Sep 1996

• Biliblanket Plus High Output Phototherapy System

  Class II

  FDA 510(k) K993712 Active Cleared 9 Nov 1999

• Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K871398 Active Cleared 7 May 1987

• Ohmeda 9000 Syringe Pump

  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

See all devices from Ohmeda Medical →

• Is the Ohmeda 5410 Volume Monitor designed for single-use or can it be reused after proper sterilization?

  The Ohmeda 5410 Volume Monitor is supplied as a reusable medical instrument. Since it is intended for clinical use in settings like operating rooms and hospitals, it must be sterilized and maintained according to the manufacturer’s guidelines to ensure safety and functionality for repeated use.

• What types of clinical environments is the Ohmeda 5410 Volume Monitor intended for?

  The device is specifically designed for use in clinical settings such as operating rooms, hospitals, and clinics, where respiratory volume monitoring is critical during surgical procedures, particularly in conjunction with anesthesia systems.

• How is the regulatory status of the Ohmeda 5410 Volume Monitor determined?

  The device holds an FDA 510(k) clearance, meaning it was reviewed by the FDA as substantially equivalent to a legally marketed predicate device. It is classified as a Class 2 Anesthesiology device under product code BZK and is regulated under 21 CFR 868.1850. The clearance was granted in 1986 via a traditional review process.

• What is the primary function of the Ohmeda 5410 Volume Monitor in patient care?

  The Ohmeda 5410 Volume Monitor is a spirometer that measures and displays lung volume changes during mechanical ventilation or spontaneous breathing. This aids clinicians in assessing patient respiratory status and managing ventilation effectively during surgical procedures.