Penlon 53454
by Penlon, Ltd.
Penlon 53454 is a Class II device made by Penlon, Ltd., cleared under FDA 510(k) K053564 on 3 Mar 2006 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05051977000260), 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 | Number05051977000260 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053564 | Date3 Mar 2006 | StatusActive |
Official records
- AccessGUDID record 05051977000260
- FDA 510(k) database K053564
Across registries
- FDA 510(k) K053564 decided 3 Mar 2006 Active
- FDA GUDID UDI-DI 05051977000260 listed 7 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K053564
- Listed FDA GUDID 05051977000260
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Penlon
- Generic name
- Sevoflurane anaesthesia vaporizer
- Model / Ref / Catalog
- 53454
- Primary DI / UDI-DI
- 05051977000260
- 510(k) Number
- FDA product code
- CAD
- GMDN term
- Sevoflurane anaesthesia vaporizer
- Device class
- Class II
- Regulation number
- 868.5880
- GUDID distribution status
- In Commercial Distribution
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