Transcend CPAP Unit
by Somnetics International, Inc
Transcend CPAP Unit (503002) is a Class II device made by Somnetics International, Inc, cleared under FDA 510(k) K100121 on 13 Jul 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI M9505030020), 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 | NumberM9505030020 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100121 | Date13 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K100121
Across registries
- FDA 510(k) K100121 decided 13 Jul 2010 Active
- FDA GUDID UDI-DI M9505030020 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K100121
- Listed FDA GUDID M9505030020
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- Withdrawn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
- CPAP Unit, 503002
- Primary DI / UDI-DI
- M9505030020
- 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
- Height — 95 MillimeterWidth — 105 MillimeterLength — 190 Millimeter
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