Cleared Traditional

K202531 - Azer Scientific Universal Transport Medium (FDA 510(k) Clearance)

Class I Microbiology device.

K202531 · Azer Scientific, Inc. · Microbiology device
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Apr 2024
Decision
1318d
Days
Class 1
Risk

K202531 is an FDA 510(k) clearance for the Azer Scientific Universal Transport Medium. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Azer Scientific, Inc. (Morgantown, US). The FDA issued a Cleared decision on April 11, 2024 after a review of 1318 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Azer Scientific, Inc. devices

Submission Details

510(k) Number K202531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date April 11, 2024
Days to Decision 1318 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1216d slower than avg
Panel avg: 102d · This submission: 1318d
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 Peers - JSM Culture Media, Non-propagating Transport

All 110
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