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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 / K262196

510(k) cleared

Invisalign System

Align Technology, Inc. · Sep 25, 2026 · K262196

FDA cleared the Invisalign System from Align Technology, Inc. on Sep 25, 2026 under K262196, a traditional 510(k). The device falls under product code PNN, Orthodontic Software, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 29, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Align Technology, Inc. has 3 other decisions in the tracker over the last 12 months: K261847 (iTero Lumina Pro), K252931 (Invisalign® Palatal Expander System), K252870 (Invisalign Specifix Attachment System).

Questions & Answers

What did FDA clear under K262196?

K262196 is the FDA 510(k) for Invisalign System, submitted by Align Technology, Inc.. FDA's decision date was Sep 25, 2026, under product code PNN (Orthodontic Software).

Who makes the Invisalign System?

Align Technology, Inc., based in San Jose, CA, is the applicant of record for K262196.

How long did the K262196 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Sep 25, 2026, 88 days later.

← All decisions in September 2026

Sources