Cleared Traditional

K252389 - Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (FDA 510(k) Clearance)

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

K252389 · Smwmed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
266d
Days
Class 2
Risk

K252389 is an FDA 510(k) clearance for the Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Smwmed, Inc. (San Diego, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 266 days - an extended review cycle.

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 Smwmed, Inc. devices

Submission Details

510(k) Number K252389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2025
Decision Date April 23, 2026
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
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

Feiying Drug & Medical Consulting Technical Service Group
Youshan Gong

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 K252389.
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
S-Patch (S-Patch ExL)
K233906 · Wellysis Corp. · Feb 2024