Cleared Traditional

KaiBiLi Extended ViralTrans (K231027) - FDA 510(k) Clearance

Class I Microbiology device.

K231027 · Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. · Microbiology device
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Dec 2023
Decision
254d
Days
Class 1
Risk

K231027 is an FDA 510(k) clearance for the KaiBiLi Extended ViralTrans. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 21, 2023 after a review of 254 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 Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. devices

Submission Details

510(k) Number K231027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2023
Decision Date December 21, 2023
Days to Decision 254 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
152d slower than avg
Panel avg: 102d · This submission: 254d
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 38
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K231027.
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BioSci™ Disposable Virus Sampling Tubes
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