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Eclipse Oxygen Concentrator 6900-SEQ

by Caire Inc.

Eclipse Oxygen Concentrator 6900-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 M7666900SEQ0), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K013931

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM7666900SEQ0 UDI-DI Date1 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013931 Date27 Mar 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013931 decided 27 Mar 2002 Active
  • FDA GUDID UDI-DI M7666900SEQ0 listed 1 Jul 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0567-2010 FDA Unclassified (pre-2012) initiated 1 Oct 2009

    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

3 dated events

  1. Cleared FDA 510(k) K013931
  2. Recall initiated FDA recalls Z-0567-2010
  3. Listed FDA GUDID M7666900SEQ0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Eclipse Oxygen Concentrator
Generic name
Mobile/portable oxygen concentrator
Model / reference
6900-SEQ
Primary DI / UDI-DI
M7666900SEQ0
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

Related devices

Category: Mobile/portable oxygen concentrator

Cleared under the same submission (K013931)

and 3 more cleared under K013931

Similar devices in this category

Other devices filed under Mobile/portable oxygen concentrator.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)