Cleared Traditional

K212743 - MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (FDA 510(k) Clearance)

Class I Microbiology device.

K212743 · Medschenker, Inc. · Microbiology device
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May 2023
Decision
611d
Days
Class 1
Risk

K212743 is an FDA 510(k) clearance for the MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medschenker, Inc. (Mahwah, US). The FDA issued a Cleared decision on May 3, 2023 after a review of 611 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 Medschenker, Inc. devices

Submission Details

510(k) Number K212743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2021
Decision Date May 03, 2023
Days to Decision 611 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
509d slower than avg
Panel avg: 102d · This submission: 611d
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

Iuvo Consulting, LLC
Rhonda Alexander

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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