510(k) K261807

Sequential Circulator (SC-4004-DL, SC-4008-DL) by Bio Compression Systems, Inc. — Product Code JOW

K261807 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "Sequential Circulator (SC-4004-DL, SC-4008-DL)". The FDA issued a decision of Substantially Equivalent on September 11, 2026. 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.