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510(k) K131327

BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM by Bio Compression Systems, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2013
Date Received
May 8, 2013
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.

  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • 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)
  • 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)
  • 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)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)