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The Tracker / September 2026 / K254240

510(k) cleared

Echo-2

Neko Health AB · Sep 22, 2026 · K254240

FDA cleared the Echo-2 from Neko Health AB on Sep 22, 2026 under K254240, a traditional 510(k). The device falls under product code QOK, Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate, regulated at 21 CFR 870.2786 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neko Health AB has 2 other decisions in the tracker over the last 12 months: K254129 (Spectrum-2), K253911 (Derma-2).

Questions & Answers

What did FDA clear under K254240?

K254240 is the FDA 510(k) for Echo-2, submitted by Neko Health AB. FDA's decision date was Sep 22, 2026, under product code QOK (Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate).

Who makes the Echo-2?

Neko Health AB, based in Danderyd, is the applicant of record for K254240.

How long did the K254240 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 22, 2026, 267 days later.

← All decisions in September 2026

Sources