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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 / June 2026 / K252963

510(k) cleared

BTL-899TT

BTL Industries, Inc. · Jun 12, 2026 · K252963

FDA cleared the BTL-899TT from BTL Industries, Inc. on Jun 12, 2026 under K252963, a traditional 510(k). The device falls under product code IMJ, Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, regulated at 21 CFR 890.5290 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 17, 2025. The decision came 268 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: K253750 (BTL-785NEH), K252561 (BTL-754FF).

Questions & Answers

What did FDA clear under K252963?

K252963 is the FDA 510(k) for BTL-899TT, submitted by BTL Industries, Inc.. FDA's decision date was Jun 12, 2026, under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat).

Who makes the BTL-899TT?

BTL Industries, Inc., based in Marlborough, MA, is the applicant of record for K252963.

How long did the K252963 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Jun 12, 2026, 268 days later.

← All decisions in June 2026

Sources