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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 / September 2025 / K252374

510(k) cleared

Nylon flexTAP(R)

Airway Technologies D/B/A Airway Management · Sep 11, 2025 · K252374

FDA cleared the Nylon flexTAP(R) from Airway Technologies D/B/A Airway Management on Sep 11, 2025 under K252374, a special 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 Jul 30, 2025. The decision came 43 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Airway Technologies D/B/A Airway Management in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252374?

K252374 is the FDA 510(k) for Nylon flexTAP(R), submitted by Airway Technologies D/B/A Airway Management. FDA's decision date was Sep 11, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Nylon flexTAP(R)?

Airway Technologies D/B/A Airway Management, based in Farmers Branch, TX, is the applicant of record for K252374.

How long did the K252374 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Sep 11, 2025, 43 days later.

← All decisions in September 2025