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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 / K260114

510(k) cleared

Align® Cover and Pad Guidance Tool

CIVCO Medical Instruments Co., Inc. · Sep 24, 2026 · K260114

FDA cleared the Align® Cover and Pad Guidance Tool from CIVCO Medical Instruments Co., Inc. on Sep 24, 2026 under K260114, a traditional 510(k). The device falls under product code ITX, Transducer, Ultrasonic, Diagnostic, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 14, 2026. The decision came 253 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 CIVCO Medical Instruments Co., Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260114?

K260114 is the FDA 510(k) for Align® Cover and Pad Guidance Tool, submitted by CIVCO Medical Instruments Co., Inc.. FDA's decision date was Sep 24, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the Align® Cover and Pad Guidance Tool?

CIVCO Medical Instruments Co., Inc., based in Coralville, IA, is the applicant of record for K260114.

How long did the K260114 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Sep 24, 2026, 253 days later.

← All decisions in September 2026