Transcend 365 miniCPAP System
by Somnetics International, Inc
Transcend 365 miniCPAP System (503102) is a Class II device made by Somnetics International, Inc, cleared under FDA 510(k) K180388 on 30 Nov 2018 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI M9505031020), active as of 23 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 | NumberM9505031020 | Date31 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180388 | Date30 Nov 2018 | StatusActive |
Official records
- FDA 510(k) database K180388
Across registries
- FDA 510(k) K180388 decided 30 Nov 2018 Active
- FDA GUDID UDI-DI M9505031020 listed 31 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K180388
- Listed FDA GUDID M9505031020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Transcend
- Generic name
- Home CPAP unit
- Model / Ref / Catalog
- 365 miniCPAP System, 503102
- Primary DI / UDI-DI
- M9505031020
- 510(k) Number
- FDA product code
- BZD
- GMDN term
- Home CPAP unit
- Device class
- Class II
- Regulation number
- 868.5905
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 7.8 InchWidth — 3.8 InchHeight — 4.5 Inch
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