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510(k) K250805

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) by Devilbiss Healthcare, LLC — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2025
Date Received
March 17, 2025
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 Devilbiss Healthcare, LLC

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  • K152810 — DeVilbiss DV6WM Wireless Modem (January 21, 2016)
  • K143677 — DeVilbiss Intellipap2/DeVilbiss BLUE (September 18, 2015)
  • K140880 — DEVILBISS SMARTLINK II SYSTEM (August 4, 2014)
  • K112220 — DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL (November 22, 2011)

Other clearances for product code CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 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)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)
  • K242736 — Portable Oxygen Concentrator (Spirit-3) (June 5, 2025)