Cleared Traditional

K231289 - S-Patch Ex Wearable ECG Patch (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231289 · Wellysis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
118d
Days
Class 2
Risk

K231289 is an FDA 510(k) clearance for the S-Patch Ex Wearable ECG Patch. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Wellysis Corp. (Seoul, KR). The FDA issued a Cleared decision on August 30, 2023 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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

Submission Details

510(k) Number K231289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2023
Decision Date August 30, 2023
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 Consultant

Mcra, LLC
Nikki Batista

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 193
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K231289.
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K252389 · Smwmed, Inc. · Apr 2026
VitaloJAK Clinic (Model 7100)
K253293 · Vitalograph , Ltd. · Dec 2025
Zio® monitor (DFG0001)
K243650 · iRhythm Technologies, Inc. · Aug 2025
AeviceMD
K243603 · Aevice Health Pte. , Ltd. · May 2025
AT-Patch (ATP-C130/ATP-C70)
K242583 · Atsens Co., Ltd. · May 2025
HiCardi+ H100
K232670 · MEZOO Co., Ltd. · Sep 2024