Cleared Traditional

K232823 - MCG-S (AM1000)

K232823 is an FDA 510(k) clearance for MCG-S (AM1000), manufactured by Amcg Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K232823 · Amcg Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
205d
Days
Class 2
Risk

K232823 is an FDA 510(k) clearance for the MCG-S (AM1000). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Amcg Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 5, 2024 after a review of 205 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 Amcg Co., Ltd. devices

FDA 510(k) Submission Details - K232823

510(k) Number K232823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2023
Decision Date April 05, 2024
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 283
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K232823.
Impala
K232035 · AliveCor, Inc. · Jun 2024
Electrocardiograph, model: ECG301
K232816 · Shenzhen LE Medical Technology Co., Ltd. · Jun 2024
CSF-4 (CSF-4)
K232445 · Cardiacsense · May 2024
Cardio Q50, Cardio Q70
K231160 · Bionet Co., Ltd. · Dec 2023
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K230834 · Trismed Co., Ltd. · Nov 2023
Masimo W1
K232512 · Masimo Corporation · Nov 2023