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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 / K251105

510(k) cleared

Tetra (TM-20); Tetra (TM-50)

Emed Technologies Corporation · Dec 22, 2025 · K251105

FDA cleared the Tetra (TM-20); Tetra (TM-50) from Emed Technologies Corporation on Dec 22, 2025 under K251105, a traditional 510(k). The device falls under product code PKP, Immunoglobulin G (Igg) Infusion System, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 11, 2025. The decision came 255 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 Emed Technologies Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251105?

K251105 is the FDA 510(k) for Tetra (TM-20); Tetra (TM-50), submitted by Emed Technologies Corporation. FDA's decision date was Dec 22, 2025, under product code PKP (Immunoglobulin G (Igg) Infusion System).

Who makes the Tetra (TM-20); Tetra (TM-50)?

Emed Technologies Corporation, based in El Dorado Hills, CA, is the applicant of record for K251105.

How long did the K251105 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Dec 22, 2025, 255 days later.

← All decisions in December 2025