Cleared Traditional

Bio Arterial Deluxe (IC-BAP-DX)

K250974 · Bio Compression Systems, Inc. · Cardiovascular
Dec 2025
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K250974 is an FDA 510(k) clearance for the Bio Arterial Deluxe (IC-BAP-DX), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on December 12, 2025, 256 days after receiving the submission on March 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K250974 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date December 12, 2025
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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