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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 / K261262

510(k) cleared

Altis Full Face Mask

Respironics, Inc. · Sep 25, 2026 · K261262

FDA cleared the Altis Full Face Mask from Respironics, Inc. on Sep 25, 2026 under K261262, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 16, 2026. The decision came 162 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 Respironics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261262?

K261262 is the FDA 510(k) for Altis Full Face Mask, submitted by Respironics, Inc.. FDA's decision date was Sep 25, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the Altis Full Face Mask?

Respironics, Inc., based in Murrysville, PA, is the applicant of record for K261262.

How long did the K261262 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Sep 25, 2026, 162 days later.

← All decisions in September 2026