Schuco S5200
Schuco S5200 is a nebulizing system delivery set (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Allied Medical LLC, cleared under FDA 510(k) K043238 on 6 Jul 2005 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00026072011706), 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 | Number00026072011706 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043238 | Date6 Jul 2005 | StatusActive |
Official records
- AccessGUDID record 00026072011706
- FDA 510(k) database K043238
Across registries
- FDA 510(k) K043238 decided 6 Jul 2005 Active
- FDA GUDID UDI-DI 00026072011706 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K043238
- Listed FDA GUDID 00026072011706
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Schuco
- Generic name
- Nebulizing system delivery set, reusable
- Model / Ref / Catalog
- S5200
- Primary DI / UDI-DI
- 00026072011706
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- Nebulizing system delivery set, reusable
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
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