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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 / K261725

510(k) cleared

OtoCompanion (Version 1.0)

Ironsides Medical, Inc. · Sep 21, 2026 · K261725

FDA cleared the OtoCompanion (Version 1.0) from Ironsides Medical, Inc. on Sep 21, 2026 under K261725, a traditional 510(k). The device falls under product code SHL, Ear, Nose, And Throat Image Analyzer, regulated at 21 CFR 874.4775 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on May 26, 2026. The decision came 118 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 Ironsides Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261725?

K261725 is the FDA 510(k) for OtoCompanion (Version 1.0), submitted by Ironsides Medical, Inc.. FDA's decision date was Sep 21, 2026, under product code SHL (Ear, Nose, And Throat Image Analyzer).

Who makes the OtoCompanion (Version 1.0)?

Ironsides Medical, Inc., based in Cambridge, MA, is the applicant of record for K261725.

How long did the K261725 review take?

FDA received the submission on May 26, 2026 and issued its decision on Sep 21, 2026, 118 days later.

← All decisions in September 2026