K240235 - OmniTrans Transport System (FDA 510(k) Clearance)

K240235 is an FDA 510(k) clearance for the OmniTrans Transport System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 19, 2024 after a review of 203 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.

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