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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 / K254230

510(k) cleared

CapsoView (CVV); CapsoCloud (CLD)

CapsoVision, Inc. · Sep 25, 2026 · K254230

FDA cleared the CapsoView (CVV); CapsoCloud (CLD) from CapsoVision, Inc. on Sep 25, 2026 under K254230, a traditional 510(k). The device falls under product code QZF, Gastrointestinal Capsule Endoscopy Analysis Software Device, regulated at 21 CFR 876.1540 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 29, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

CapsoVision, Inc. has one other decision in the tracker over the last 12 months: K252480 (CE Deliver (DLV)).

Questions & Answers

What did FDA clear under K254230?

K254230 is the FDA 510(k) for CapsoView (CVV); CapsoCloud (CLD), submitted by CapsoVision, Inc.. FDA's decision date was Sep 25, 2026, under product code QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device).

Who makes the CapsoView (CVV); CapsoCloud (CLD)?

CapsoVision, Inc., based in Saratoga, CA, is the applicant of record for K254230.

How long did the K254230 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 25, 2026, 270 days later.

← All decisions in September 2026

Sources