WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262559

510(k) cleared

Mouth Guard

ChangSha ChuangDuoLe E-Commerce Co., Ltd. · Sep 16, 2026 · K262559

FDA cleared the Mouth Guard from ChangSha ChuangDuoLe E-Commerce Co., Ltd. on Sep 16, 2026 under K262559, a traditional 510(k). The device falls under product code OBR, Mouthguard, Over-The-Counter as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 24, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for ChangSha ChuangDuoLe E-Commerce Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262559?

K262559 is the FDA 510(k) for Mouth Guard, submitted by ChangSha ChuangDuoLe E-Commerce Co., Ltd.. FDA's decision date was Sep 16, 2026, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the Mouth Guard?

ChangSha ChuangDuoLe E-Commerce Co., Ltd., based in Changsha, is the applicant of record for K262559.

How long did the K262559 review take?

FDA received the submission on Jul 24, 2026 and issued its decision on Sep 16, 2026, 54 days later.

← All decisions in September 2026