Oxus Sieve Beds
by Oxus, Inc. 510(k)
Active
510(k) K211056
Overview
The Oxus Sieve Beds are components designed for use with portable oxygen generators. Each unit consists of a sieve tube, wave spring, sieve cap, plastic diffuser, O-rings, seal, zeolite, and alumina.
These replacement beds are user-installed components. This device has received FDA 510(k) clearance under the product code CAW and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211056 | Date31 May 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Oxus, Inc.
Questions
What are Oxus Sieve Beds used for?
These units serve as essential components for portable oxygen generators. They contain the necessary materials, including zeolite and alumina, to facilitate the function of the oxygen generation system.
Can I install the Oxus Sieve Beds myself?
Yes, these replacement beds are designed as user-installed components, allowing for maintenance of the portable oxygen generator without requiring professional service.
What components are included in each Oxus Sieve Bed unit?
Each unit is a complete assembly consisting of a sieve tube, wave spring, sieve cap, plastic diffuser, O-rings, a seal, and the active filtration materials, zeolite and alumina.
What is the regulatory status of this device?
The Oxus Sieve Beds are classified as a Class II medical device and have received FDA 510(k) clearance under product code CAW.