Cleared Traditional

K254119 - Wearable ECG Recorder (YMHeart XY-12)

Also marketed or referenced as:
Wearable ECG Recorder (YMHeart XY-1201) Wearable ECG Recorder (YMHeart XY-1202) Wearable ECG Recorder (YMHeart XY-1203) Wearable ECG Recorder (YMHeart XY-03) Wearable ECG Recorder (YMHeart XY-0301) Wearable ECG Recorder (YMHeart XY-0302) Wearable ECG Recorder (YMHeart XY-0303)

K254119 is an FDA 510(k) clearance for Wearable ECG Recorder (YMHeart XY-12), manufactured by Shenzhen Xinyan Medical Technology Co.,ltd.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K254119 · Shenzhen Xinyan Medical Technology Co.,ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
266d
Days
Class 2
Risk

K254119 is an FDA 510(k) clearance for the Wearable ECG Recorder (YMHeart XY-12). Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Shenzhen Xinyan Medical Technology Co.,ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 11, 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 Shenzhen Xinyan Medical Technology Co.,ltd. devices

FDA 510(k) Submission Details - K254119

510(k) Number K254119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date September 11, 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.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
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

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 59
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K254119.
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