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 / May 2026 / K253911

510(k) cleared

Derma-2

Neko Health AB · May 20, 2026 · K253911

FDA cleared the Derma-2 from Neko Health AB on May 20, 2026 under K253911, a traditional 510(k). The device falls under product code LHQ, System, Telethermographic (Adjunctive Use), regulated at 21 CFR 884.2980 as a Class 1 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 8, 2025. The decision came 163 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neko Health AB has one other decision in the tracker over the last 12 months: K254129 (Spectrum-2).

Questions & Answers

What did FDA clear under K253911?

K253911 is the FDA 510(k) for Derma-2, submitted by Neko Health AB. FDA's decision date was May 20, 2026, under product code LHQ (System, Telethermographic (Adjunctive Use)).

Who makes the Derma-2?

Neko Health AB, based in Danderyd, is the applicant of record for K253911.

How long did the K253911 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on May 20, 2026, 163 days later.

← All decisions in May 2026

Sources