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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 / April 2026 / K252079

510(k) cleared

Disposable Infusion Bag for Parenteral Nutrition

Beijing L&Z Medical Technology Development Co., Ltd. · Apr 2, 2026 · K252079

FDA cleared the Disposable Infusion Bag for Parenteral Nutrition from Beijing L&Z Medical Technology Development Co., Ltd. on Apr 2, 2026 under K252079, a traditional 510(k). The device falls under product code KPE, Container, I.V., regulated at 21 CFR 880.5025 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 2, 2025. The decision came 274 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 Beijing L&Z Medical Technology Development Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252079?

K252079 is the FDA 510(k) for Disposable Infusion Bag for Parenteral Nutrition, submitted by Beijing L&Z Medical Technology Development Co., Ltd.. FDA's decision date was Apr 2, 2026, under product code KPE (Container, I.V.).

Who makes the Disposable Infusion Bag for Parenteral Nutrition?

Beijing L&Z Medical Technology Development Co., Ltd., based in Beijing, is the applicant of record for K252079.

How long did the K252079 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Apr 2, 2026, 274 days later.

← All decisions in April 2026