WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K260691

510(k) cleared

BTL-699

BTL Industries, Inc. · Aug 23, 2026 · K260691

FDA cleared the BTL-699 from BTL Industries, Inc. on Aug 23, 2026 under K260691, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 3, 2026. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BTL Industries, Inc. has 3 other decisions in the tracker over the last 12 months: K252963 (BTL-899TT), K253750 (BTL-785NEH), K252561 (BTL-754FF).

Questions & Answers

What did FDA clear under K260691?

K260691 is the FDA 510(k) for BTL-699, submitted by BTL Industries, Inc.. FDA's decision date was Aug 23, 2026, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the BTL-699?

BTL Industries, Inc., based in Marlborough, MA, is the applicant of record for K260691.

How long did the K260691 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Aug 23, 2026, 173 days later.

← All decisions in August 2026

Sources