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 / January 2026 / K252496

510(k) cleared

Neurophet AQUA AD Plus

Neurophet., Inc. · Jan 29, 2026 · K252496

FDA cleared the Neurophet AQUA AD Plus from Neurophet., Inc. on Jan 29, 2026 under K252496, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 8, 2025. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neurophet., Inc. has 2 other decisions in the tracker over the last 12 months: K252563 (Neurophet SCALE PET), K261273 (Neurophet AQUA).

Questions & Answers

What did FDA clear under K252496?

K252496 is the FDA 510(k) for Neurophet AQUA AD Plus, submitted by Neurophet., Inc.. FDA's decision date was Jan 29, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Neurophet AQUA AD Plus?

Neurophet., Inc., based in Seoul, is the applicant of record for K252496.

How long did the K252496 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Jan 29, 2026, 174 days later.

← All decisions in January 2026

Sources