WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K242976

510(k) cleared

Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

Medical Wire & Equipment Company (Bath), Ltd. · Nov 26, 2025 · K242976

FDA cleared the Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device from Medical Wire & Equipment Company (Bath), Ltd. on Nov 26, 2025 under K242976, a traditional 510(k). The device falls under product code JSM, Culture Media, Non-Propagating Transport, regulated at 21 CFR 866.2390 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 26, 2024. The decision came 426 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medical Wire & Equipment Company (Bath), Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242976?

K242976 is the FDA 510(k) for Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device, submitted by Medical Wire & Equipment Company (Bath), Ltd.. FDA's decision date was Nov 26, 2025, under product code JSM (Culture Media, Non-Propagating Transport).

Who makes the Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device?

Medical Wire & Equipment Company (Bath), Ltd., based in Corsham, is the applicant of record for K242976.

How long did the K242976 review take?

FDA received the submission on Sep 26, 2024 and issued its decision on Nov 26, 2025, 426 days later.

← All decisions in November 2025