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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 / K260313

510(k) cleared

MD-6000S Bladder Scanner

MEDA Co., Ltd. · Sep 24, 2026 · K260313

FDA cleared the MD-6000S Bladder Scanner from MEDA Co., Ltd. on Sep 24, 2026 under K260313, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 30, 2026. The decision came 237 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 MEDA Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260313?

K260313 is the FDA 510(k) for MD-6000S Bladder Scanner, submitted by MEDA Co., Ltd.. FDA's decision date was Sep 24, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the MD-6000S Bladder Scanner?

MEDA Co., Ltd., based in Tianjin, is the applicant of record for K260313.

How long did the K260313 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Sep 24, 2026, 237 days later.

← All decisions in September 2026