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510(k) K252399

Portable Oxygen Concentrator by Honsun (Nantong) Co., Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2026
Date Received
July 31, 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

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  • K130925 — AUTOMATIC BLOOD PRESSURE MONITOR (September 12, 2013)
  • K131463 — WRIST AUTOMATIC BLOOD PRESSURE MONITOR (July 8, 2013)

Other clearances for product code CAW

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  • K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555) (March 26, 2026)
  • 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)
  • 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)