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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 / March 2026 / K253750

510(k) cleared

BTL-785NEH

BTL Industries, Inc. · Mar 17, 2026 · K253750

FDA cleared the BTL-785NEH from BTL Industries, Inc. on Mar 17, 2026 under K253750, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 25, 2025. The decision came 112 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BTL Industries, Inc. has 2 other decisions in the tracker over the last 12 months: K252963 (BTL-899TT), K252561 (BTL-754FF).

Questions & Answers

What did FDA clear under K253750?

K253750 is the FDA 510(k) for BTL-785NEH, submitted by BTL Industries, Inc.. FDA's decision date was Mar 17, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the BTL-785NEH?

BTL Industries, Inc., based in Marlborough, MA, is the applicant of record for K253750.

How long did the K253750 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Mar 17, 2026, 112 days later.

← All decisions in March 2026

Sources