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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 / K262442

510(k) cleared

HipStudio Analysis

Replasia BV · Sep 22, 2026 · K262442

FDA cleared the HipStudio Analysis from Replasia BV on Sep 22, 2026 under K262442, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 16, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Replasia BV in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262442?

K262442 is the FDA 510(k) for HipStudio Analysis, submitted by Replasia BV. FDA's decision date was Sep 22, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the HipStudio Analysis?

Replasia BV, based in Leuven, is the applicant of record for K262442.

How long did the K262442 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Sep 22, 2026, 68 days later.

← All decisions in September 2026