S-Patch CardioAI— 510(k) K254255

Name: FDA 510(k) clearance K254255
Creator: U.S. Food and Drug Administration
Published: 2026-09-25

Substantially Equivalent

Wellysis Corp.

FDA 510(k) clearance K254255 for S-Patch CardioAI, Substantially Equivalent on 2026-09-25. Applicant: Wellysis Corp.. Device class: 2.

Summary

S-Patch CardioAI from Wellysis Corp. is filed under DPS, electrocardiographs. The "Patch" name suggests a wearable ECG patch and "AI" suggests automated analysis, but the record doesn't confirm either.

Class II, 21 CFR 870.2340. The Cardiovascular panel reviewed it as a Traditional 510(k).

Wellysis filed from Seoul, South Korea. Review took 270 days (December 29, 2025 to September 25, 2026).

Clearance details

Applicant: Wellysis Corp.
Product code: Product code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

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K260005 — MyoVista wavECG (DG-200-B15-003)2026-10-05
K260250 — QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)2026-09-29
K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22

More clearances from Wellysis Corp.

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K233906 — S-Patch (S-Patch ExL)2024-02-16
K231289 — S-Patch Ex Wearable ECG Patch2023-08-30

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.