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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 / March 2026 / K253442

510(k) cleared

EarliPoint Assessment

Earlitec Diagnostics · Mar 5, 2026 · K253442

FDA cleared the EarliPoint Assessment from Earlitec Diagnostics on Mar 5, 2026 under K253442, a traditional 510(k). The device falls under product code QPF, Pediatric Autism Spectrum Disorder Diagnosis Aid, regulated at 21 CFR 882.1491 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Oct 1, 2025. The decision came 155 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 Earlitec Diagnostics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253442?

K253442 is the FDA 510(k) for EarliPoint Assessment, submitted by Earlitec Diagnostics. FDA's decision date was Mar 5, 2026, under product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid).

Who makes the EarliPoint Assessment?

Earlitec Diagnostics, based in Plymouth, MN, is the applicant of record for K253442.

How long did the K253442 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Mar 5, 2026, 155 days later.

← All decisions in March 2026