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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 / K262421

510(k) cleared

Daybreak Impression Material

Sleepcare, LLC · Oct 20, 2026 · K262421

FDA cleared the Daybreak Impression Material from Sleepcare, LLC on Oct 20, 2026 under K262421, a traditional 510(k). The device falls under product code SHI, Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 16, 2026. The decision came 96 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 Sleepcare, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262421?

K262421 is the FDA 510(k) for Daybreak Impression Material, submitted by Sleepcare, LLC. FDA's decision date was Oct 20, 2026, under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter).

Who makes the Daybreak Impression Material?

Sleepcare, LLC, based in Los Angeles, CA, is the applicant of record for K262421.

How long did the K262421 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Oct 20, 2026, 96 days later.

← All decisions in October 2026