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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 / February 2026 / K243348

510(k) cleared

Athelas Home

Athelas, Inc. · Feb 6, 2026 · K243348

FDA cleared the Athelas Home from Athelas, Inc. on Feb 6, 2026 under K243348, a traditional 510(k). The device falls under product code GKZ, Counter, Differential Cell, regulated at 21 CFR 864.5220 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Oct 28, 2024. The decision came 466 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 Athelas, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243348?

K243348 is the FDA 510(k) for Athelas Home, submitted by Athelas, Inc.. FDA's decision date was Feb 6, 2026, under product code GKZ (Counter, Differential Cell).

Who makes the Athelas Home?

Athelas, Inc., based in Mountain View, CA, is the applicant of record for K243348.

How long did the K243348 review take?

FDA received the submission on Oct 28, 2024 and issued its decision on Feb 6, 2026, 466 days later.

← All decisions in February 2026