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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 / December 2025 / K252497

510(k) cleared

SANSA HSAT

Huxley Medical · Dec 10, 2025 · K252497

FDA cleared the SANSA HSAT from Huxley Medical on Dec 10, 2025 under K252497, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 8, 2025. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Huxley Medical has one other decision in the tracker over the last 12 months: K250882 (SANSA HSAT).

Questions & Answers

What did FDA clear under K252497?

K252497 is the FDA 510(k) for SANSA HSAT, submitted by Huxley Medical. FDA's decision date was Dec 10, 2025, under product code MNR (Ventilatory Effort Recorder).

Who makes the SANSA HSAT?

Huxley Medical, based in Atlanta, GA, is the applicant of record for K252497.

How long did the K252497 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Dec 10, 2025, 124 days later.

← All decisions in December 2025