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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262353

510(k) cleared

BTL-299-F

BTL Industries, Inc. · Sep 23, 2026 · K262353

FDA cleared the BTL-299-F from BTL Industries, Inc. on Sep 23, 2026 under K262353, a traditional 510(k). The device falls under product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence, regulated at 21 CFR 876.5320 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 10, 2026. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

BTL Industries, Inc. has 4 other decisions in the tracker over the last 12 months: K260691 (BTL-699), K252963 (BTL-899TT), K253750 (BTL-785NEH), K252561 (BTL-754FF).

Questions & Answers

What did FDA clear under K262353?

K262353 is the FDA 510(k) for BTL-299-F, submitted by BTL Industries, Inc.. FDA's decision date was Sep 23, 2026, under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Who makes the BTL-299-F?

BTL Industries, Inc., based in Marlborough, MA, is the applicant of record for K262353.

How long did the K262353 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Sep 23, 2026, 75 days later.

← All decisions in September 2026

Sources