K242976 - Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (FDA 510(k) Clearance)

K242976 is an FDA 510(k) clearance for the Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport.... Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, GB). The FDA issued a Cleared decision on November 26, 2025 after a review of 426 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.

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