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510(k) K240499

ARTAIRA Arterial Compression Device (AACD01) by Airos Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
February 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Airos Medical, Inc.

  • K223195 — AIROS 6P Sequential Compression Device (December 9, 2022)
  • K223193 — AIROS 8P Sequential Compression Device (December 9, 2022)
  • K193069 — AIROS 6 Sequential Compression Device (December 4, 2019)
  • K193068 — AIROS 8 Sequential Compression Device (December 4, 2019)
  • K172779 — AIROS 8 Sequential Compression Device (June 22, 2018)
  • K172770 — AIROS 6 Sequential Compression Device (June 22, 2018)

Other clearances for product code JOW

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)
  • K232640 — Venowave VW5 (June 25, 2024)