510(k) K250974

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

K250974 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "Bio Arterial Deluxe (IC-BAP-DX)". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.