Discov-R 70051
Discov-R 70051 is a Class II device made by Belluscura PLC, cleared under FDA 510(k) K203086 on 2 Mar 2021 and listed in FDA GUDID since 18 Apr 2025 (UDI-DI 00850029991076), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850029991076 | Date18 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203086 | Date2 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 00850029991076
- FDA 510(k) database K203086
Across registries
- FDA 510(k) K203086 decided 2 Mar 2021 Active
- FDA GUDID UDI-DI 00850029991076 listed 18 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K203086
- Listed FDA GUDID 00850029991076
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Discov-R
- Generic name
- Mobile/portable oxygen concentrator
- Model / reference
- 70051
- Primary DI / UDI-DI
- 00850029991076
- 510(k) Number
- FDA product code
- CAW
- GMDN term
- Mobile/portable oxygen concentrator
- Device class
- Class II
- Regulation number
- 868.5440
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Mobile/portable oxygen concentrator.