Cleared Traditional

K233449 - Avantik VTM (FDA 510(k) Clearance)

Class I Microbiology device.

K233449 · Hanchang Medic Co., Ltd. (Han Chang Medic) · Microbiology device
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Jul 2024
Decision
269d
Days
Class 1
Risk

K233449 is an FDA 510(k) clearance for the Avantik VTM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Hanchang Medic Co., Ltd. (Han Chang Medic) (Asan-Si, KR). The FDA issued a Cleared decision on July 15, 2024 after a review of 269 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hanchang Medic Co., Ltd. (Han Chang Medic) devices

Submission Details

510(k) Number K233449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2023
Decision Date July 15, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 102d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Medical Device Academy, Inc.
Gregory M. Chrysler

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.

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