Cleared Traditional

K232670 - HiCardi+ H100

K232670 is an FDA 510(k) clearance for HiCardi+ H100, manufactured by MEZOO Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K232670 · MEZOO Co., Ltd. · Cardiovascular device
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Sep 2024
Decision
385d
Days
Class 2
Risk

K232670 is an FDA 510(k) clearance for the HiCardi+ H100. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by MEZOO Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on September 20, 2024 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 MEZOO Co., Ltd. devices

FDA 510(k) Submission Details - K232670

510(k) Number K232670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2023
Decision Date September 20, 2024
Days to Decision 385 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 125d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

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 Peers - DSH Recorder, Magnetic Tape, Medical

All 78
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