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510(k) K250974

Bio Arterial Deluxe (IC-BAP-DX) by Bio Compression Systems, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
March 31, 2025
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 Bio Compression Systems, Inc.

  • K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-D (February 16, 2022)
  • K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-D (May 14, 2021)
  • K180248 — VascuEase IC-1200-WH (August 7, 2018)
  • K171793 — Sequential Circulator SC-2004FC-OC (August 17, 2017)
  • K150953 — Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (July 16, 2015)
  • K142640 — Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulato (November 6, 2014)
  • K131306 — IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE (July 22, 2013)
  • K131327 — BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (July 18, 2013)
  • K122112 — 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM (April 9, 2013)
  • K072666 — BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (November 5, 2007)

Other clearances for product code JOW

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • 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)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)
  • K232640 — Venowave VW5 (June 25, 2024)