Eclipse 3 5909-Seq
by Caire Inc.
Eclipse 3 5909-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 11 Sep 2018 (UDI-DI M7665909SEQ0), 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 | NumberM7665909SEQ0 | Date11 Sep 2018 | 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 M7665909SEQ0 listed 11 Sep 2018 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 M7665909SEQ0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eclipse 3
- Generic name
- Mobile/portable oxygen concentrator
- Model / reference
- 5909-SEQ
- Primary DI / UDI-DI
- M7665909SEQ0
- 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.