Ohmeda Autoclavable Bellows Assembly

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

510(k) Number

K921742 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K993407 Active Cleared 5 Jan 2000

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  FDA 510(k) K896023 Active Cleared 4 Jan 1990

See all devices from Ohmeda Medical →

• What is the Ohmeda Autoclavable Bellows Assembly used for?

  It is a component of anesthesia gas machines designed to regulate and deliver breathing gases during surgical procedures, functioning as part of the machine's ventilatory system to support patient respiration under anesthesia.

• Is the Ohmeda Autoclavable Bellows Assembly reusable or single-use?

  It is reusable because it is autoclavable, meaning it can withstand repeated sterilization cycles via steam autoclaving without degradation, allowing for multiple uses after proper cleaning and sterilization between patients.

• How is the Ohmeda Autoclavable Bellows Assembly supplied and sterilized?

  The device is supplied non-sterile by Ohmeda Medical and is intended to be cleaned and sterilized by the user via autoclaving before each use, as indicated by its autoclavable design and reusable nature.

• What regulatory pathway was used for the Ohmeda Autoclavable Bellows Assembly?

  It was cleared through the FDA 510(k) pathway as a substantially equivalent device, meaning it demonstrated safety and effectiveness by comparison to a legally marketed predicate device, without requiring premarket approval.

• What classification and product code apply to the Ohmeda Autoclavable Bellows Assembly?

  It is classified as a Class II medical device under FDA regulation 868.5160 with product code BSZ, which identifies it as a gas-machine anesthesia device subject to special controls for performance and safety.