Cleared Traditional

K254255 - S-Patch CardioAI

K254255 is an FDA 510(k) clearance for S-Patch CardioAI, manufactured by Wellysis Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K254255 · Wellysis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
270d
Days
Class 2
Risk

K254255 is an FDA 510(k) clearance for the S-Patch CardioAI. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Wellysis Corp. (Seoul, KR). The FDA issued a Cleared decision on September 25, 2026 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Wellysis Corp. devices

FDA 510(k) Submission Details - K254255

510(k) Number K254255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 25, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K254255.
QCA 10 Electrocardiograph (QCARD-10)
K260250 · QT Medical, Inc. · Sep 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
K252463 · Edan Instruments, Inc. · Jul 2026
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025