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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 / December 2025 / K242492

510(k) cleared

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

Techno-Path Manufacturing , Ltd. · Dec 30, 2025 · K242492

FDA cleared the Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) from Techno-Path Manufacturing , Ltd. on Dec 30, 2025 under K242492, a traditional 510(k). The device falls under product code QCH, Assayed Quality Control Material For Clinical Microbiology Assays, regulated at 21 CFR 866.3920 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Aug 21, 2024. The decision came 496 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 Techno-Path Manufacturing , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242492?

K242492 is the FDA 510(k) for Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN), submitted by Techno-Path Manufacturing , Ltd.. FDA's decision date was Dec 30, 2025, under product code QCH (Assayed Quality Control Material For Clinical Microbiology Assays).

Who makes the Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)?

Techno-Path Manufacturing , Ltd., based in Co. Tipperary, is the applicant of record for K242492.

How long did the K242492 review take?

FDA received the submission on Aug 21, 2024 and issued its decision on Dec 30, 2025, 496 days later.

← All decisions in December 2025