WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253778

510(k) cleared

Allday Moisturizing Rinse

Elevate Oral Care · Feb 27, 2026 · K253778

FDA cleared the Allday Moisturizing Rinse from Elevate Oral Care on Feb 27, 2026 under K253778, a traditional 510(k). The device falls under product code LFD, Saliva, Artificial as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 26, 2025. The decision came 93 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 Elevate Oral Care in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253778?

K253778 is the FDA 510(k) for Allday Moisturizing Rinse, submitted by Elevate Oral Care. FDA's decision date was Feb 27, 2026, under product code LFD (Saliva, Artificial).

Who makes the Allday Moisturizing Rinse?

Elevate Oral Care, based in West Palm Beach, FL, is the applicant of record for K253778.

How long did the K253778 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Feb 27, 2026, 93 days later.

← All decisions in February 2026