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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 / January 2026 / K253082

510(k) cleared

LZI Buprenorphine II Enzyme Immunoassay

Lin-Zhi International, Inc. · Jan 16, 2026 · K253082

FDA cleared the LZI Buprenorphine II Enzyme Immunoassay from Lin-Zhi International, Inc. on Jan 16, 2026 under K253082, a traditional 510(k). The device falls under product code DJG, Enzyme Immunoassay, Opiates, regulated at 21 CFR 862.3650 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Sep 23, 2025. The decision came 115 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 Lin-Zhi International, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253082?

K253082 is the FDA 510(k) for LZI Buprenorphine II Enzyme Immunoassay, submitted by Lin-Zhi International, Inc.. FDA's decision date was Jan 16, 2026, under product code DJG (Enzyme Immunoassay, Opiates).

Who makes the LZI Buprenorphine II Enzyme Immunoassay?

Lin-Zhi International, Inc., based in Santa Clara, CA, is the applicant of record for K253082.

How long did the K253082 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Jan 16, 2026, 115 days later.

← All decisions in January 2026