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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 / May 2026 / K254129

510(k) cleared

Spectrum-2

Neko Health AB · May 22, 2026 · K254129

FDA cleared the Spectrum-2 from Neko Health AB on May 22, 2026 under K254129, a traditional 510(k). The device falls under product code MUD, Oximeter, Tissue Saturation, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 22, 2025. The decision came 151 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: K253911 (Derma-2).

Questions & Answers

What did FDA clear under K254129?

K254129 is the FDA 510(k) for Spectrum-2, submitted by Neko Health AB. FDA's decision date was May 22, 2026, under product code MUD (Oximeter, Tissue Saturation).

Who makes the Spectrum-2?

Neko Health AB, based in Danderyd, is the applicant of record for K254129.

How long did the K254129 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 22, 2026, 151 days later.

← All decisions in May 2026