WHERE ARE YOU?

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

THE TAPE

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 / K260945

510(k) cleared

Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)

Fit-Pro KFT (Ltd.) - DBA E-Fit · Sep 27, 2026 · K260945

FDA cleared the Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) from Fit-Pro KFT (Ltd.) - DBA E-Fit on Sep 27, 2026 under K260945, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Mar 23, 2026. The decision came 188 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 Fit-Pro KFT (Ltd.) - DBA E-Fit in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260945?

K260945 is the FDA 510(k) for Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2), submitted by Fit-Pro KFT (Ltd.) - DBA E-Fit. FDA's decision date was Sep 27, 2026.

Who makes the Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)?

Fit-Pro KFT (Ltd.) - DBA E-Fit, based in Budapest, is the applicant of record for K260945.

How long did the K260945 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Sep 27, 2026, 188 days later.

← All decisions in September 2026