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The Tracker / September 2026 / K254255

510(k) cleared

S-Patch CardioAI

Wellysis Corp. · Sep 25, 2026 · K254255

FDA cleared the S-Patch CardioAI from Wellysis Corp. on Sep 25, 2026 under K254255, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 270 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 Wellysis Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254255?

K254255 is the FDA 510(k) for S-Patch CardioAI, submitted by Wellysis Corp.. FDA's decision date was Sep 25, 2026, under product code DPS (Electrocardiograph).

Who makes the S-Patch CardioAI?

Wellysis Corp., based in Seoul, is the applicant of record for K254255.

How long did the K254255 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 25, 2026, 270 days later.

← All decisions in September 2026