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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 / K262937

510(k) cleared

PDR Airway Device

Park Dental Research Corp. · Oct 20, 2026 · K262937

FDA cleared the PDR Airway Device from Park Dental Research Corp. on Oct 20, 2026 under K262937, a traditional 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 21, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Park Dental Research Corp. has one other decision in the tracker over the last 12 months: K252976 (Park Dental Nylon MAD).

Questions & Answers

What did FDA clear under K262937?

K262937 is the FDA 510(k) for PDR Airway Device, submitted by Park Dental Research Corp.. FDA's decision date was Oct 20, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the PDR Airway Device?

Park Dental Research Corp., based in Ardmore, OK, is the applicant of record for K262937.

How long did the K262937 review take?

FDA received the submission on Aug 21, 2026 and issued its decision on Oct 20, 2026, 60 days later.

← All decisions in October 2026

Sources