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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K250974

510(k) cleared

Bio Arterial Deluxe (IC-BAP-DX)

Bio Compression Systems, Inc. · Dec 12, 2025 · K250974

FDA cleared the Bio Arterial Deluxe (IC-BAP-DX) from Bio Compression Systems, Inc. on Dec 12, 2025 under K250974, 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 Mar 31, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bio Compression Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250974?

K250974 is the FDA 510(k) for Bio Arterial Deluxe (IC-BAP-DX), submitted by Bio Compression Systems, Inc.. FDA's decision date was Dec 12, 2025, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Bio Arterial Deluxe (IC-BAP-DX)?

Bio Compression Systems, Inc., based in Moonachie, NJ, is the applicant of record for K250974.

How long did the K250974 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Dec 12, 2025, 256 days later.

← All decisions in December 2025