Cleared Traditional

K250205 - Babio® Virus Transport Kit (Non-inactivating) (FDA 510(k) Clearance)

Class I Microbiology device.

K250205 · Jinan Babio Biotechnology Co., Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
241d
Days
Class 1
Risk

K250205 is an FDA 510(k) clearance for the Babio® Virus Transport Kit (Non-inactivating). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Jinan Babio Biotechnology Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on September 22, 2025 after a review of 241 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 Jinan Babio Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K250205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date September 22, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 102d · This submission: 241d
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

Iyou Health
Keqin Gregg

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

All 110
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K250205.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
K242976 · Medical Wire & Equipment Company (Bath), Ltd. · Nov 2025
AllTest Viral Transport Medium
K242576 · Hangzhou AllTest Biotech Co., Ltd. · Apr 2025
UriSponge™
K232565 · Copan Italia Spa · Oct 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · Ensol Biosciences, Inc. · Aug 2024
OmniTrans Transport System
K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024
Viral Transport Medium
K233534 · Hardy Diagnostics · Aug 2024