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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261807

510(k) cleared

Sequential Circulator (SC-4004-DL, SC-4008-DL)

Bio Compression Systems, Inc. · Sep 11, 2026 · K261807

FDA cleared the Sequential Circulator (SC-4004-DL, SC-4008-DL) from Bio Compression Systems, Inc. on Sep 11, 2026 under K261807, a traditional 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 1, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bio Compression Systems, Inc. has one other decision in the tracker over the last 12 months: K250974 (Bio Arterial Deluxe (IC-BAP-DX)).

Questions & Answers

What did FDA clear under K261807?

K261807 is the FDA 510(k) for Sequential Circulator (SC-4004-DL, SC-4008-DL), submitted by Bio Compression Systems, Inc.. FDA's decision date was Sep 11, 2026, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Sequential Circulator (SC-4004-DL, SC-4008-DL)?

Bio Compression Systems, Inc., based in Moonachie, NJ, is the applicant of record for K261807.

How long did the K261807 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Sep 11, 2026, 102 days later.

← All decisions in September 2026

Sources