Cleared Traditional

K243438 - MEMO Patch M (MPT-E08R-UNC01) (FDA 510(k) Clearance)

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

K243438 · Huinno Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
394d
Days
Class 2
Risk

K243438 is an FDA 510(k) clearance for the MEMO Patch M (MPT-E08R-UNC01). Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Huinno Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 5, 2025 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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. Elevated predicate reliance profile. 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 Huinno Co., Ltd. devices

Submission Details

510(k) Number K243438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2024
Decision Date December 05, 2025
Days to Decision 394 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
269d slower than avg
Panel avg: 125d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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

Lighten Bridge, LLC
Edward Park

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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 296
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K243438.
PreemptiveAI Clinical SDK
K250233 · Measure Labs, Inc. (Dba Preemptiveai, Inc.) · Feb 2026
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
K250258 · Heartbeam, Inc. · Dec 2025
Hexoskin Medical System (7100-00016)
K243981 · Carre Technologies, Inc. · Nov 2025
VitalSigns 1-Lead Holter (VSH101)
K243003 · VitalSigns Technology Co., Ltd. · Jun 2025
QT ECG (QTERD100)
K233521 · QT Medical, Inc. · Dec 2023
V-Patch Cardiac Monitor
K222842 · Shandong Corecare Technology Limited · Oct 2022