Cleared Traditional

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

Nov 2025
Decision
426d
Days
Class 1
Risk

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

Submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, GB). The FDA issued a Cleared decision on November 26, 2025, 426 days after receiving the submission on September 26, 2024.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K242976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date November 26, 2025
Days to Decision 426 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM - Culture Media, Non-propagating Transport
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2390