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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K260421

510(k) cleared

LuxDesign

LuxCreo, Inc. · Oct 23, 2026 · K260421

FDA cleared the LuxDesign from LuxCreo, Inc. on Oct 23, 2026 under K260421, 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 Feb 9, 2026. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

LuxCreo, Inc. has one other decision in the tracker over the last 12 months: K253365 (LuxCreo Flexible Partial Denture Resin).

Questions & Answers

What did FDA clear under K260421?

K260421 is the FDA 510(k) for LuxDesign, submitted by LuxCreo, Inc.. FDA's decision date was Oct 23, 2026, under product code PNN (Orthodontic Software).

Who makes the LuxDesign?

LuxCreo, Inc., based in Chicago, IL, is the applicant of record for K260421.

How long did the K260421 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Oct 23, 2026, 256 days later.

← All decisions in October 2026

Sources