Eclipse Oxygen Concentrator 5900C-SEQ
by Caire Inc.
Eclipse Oxygen Concentrator 5900C-SEQ is a Class II device made by Caire Inc., cleared under FDA 510(k) K013931 on 27 Mar 2002 and listed in FDA GUDID since 1 Jul 2015 (UDI-DI M7665900CSEQ0), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM7665900CSEQ0 | Date1 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013931 | Date27 Mar 2002 | StatusActive |
Official records
- FDA 510(k) database K013931
Across registries
- FDA 510(k) K013931 decided 27 Mar 2002 Active
- FDA GUDID UDI-DI M7665900CSEQ0 listed 1 Jul 2015 Listed
Recalls
-
- Terminated Z-0567-2010
Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.
Timeline
- Cleared FDA 510(k) K013931
- Recall initiated FDA recalls Z-0567-2010
- Listed FDA GUDID M7665900CSEQ0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eclipse Oxygen Concentrator
- Generic name
- Mobile/portable oxygen concentrator
- Model / reference
- 5900C-SEQ
- Primary DI / UDI-DI
- M7665900CSEQ0
- 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
Similar devices in this category
Other devices filed under Mobile/portable oxygen concentrator.