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510(k) K222086

Inogen Rove 4 Portable Oxygen Concentrator by Inogen — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2022
Date Received
July 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Inogen

  • K241091 — SIMEOX 200 Airway Clearance Device (December 23, 2024)
  • K230052 — Inogen Rove 6 (June 30, 2023)
  • K132489 — INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) (June 20, 2014)
  • K032818 — INOGEN ONE OXYGEN CONCENTRATOR (May 13, 2004)

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  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
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  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)