Cleared Traditional

K220908 - Ensol EnTM Specimen Collection and Transport System (FDA 510(k) Clearance)

Class I Microbiology device.

K220908 · Ensol Biosciences, Inc. · Microbiology device
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Aug 2024
Decision
884d
Days
Class 1
Risk

K220908 is an FDA 510(k) clearance for the Ensol EnTM Specimen Collection and Transport System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Ensol Biosciences, Inc. (Daejeon, KR). The FDA issued a Cleared decision on August 29, 2024 after a review of 884 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 Ensol Biosciences, Inc. devices

Submission Details

510(k) Number K220908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2022
Decision Date August 29, 2024
Days to Decision 884 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
782d slower than avg
Panel avg: 102d · This submission: 884d
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

LK Consulting Group USA, Inc.
Priscilla Chung

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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

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