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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 / K254290

510(k) cleared

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)

Shenzhen Peninsula Medical Group · Jan 30, 2026 · K254290

FDA cleared the ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) from Shenzhen Peninsula Medical Group on Jan 30, 2026 under K254290, a special 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 31, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Peninsula Medical Group in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254290?

K254290 is the FDA 510(k) for ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III), submitted by Shenzhen Peninsula Medical Group. FDA's decision date was Jan 30, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)?

Shenzhen Peninsula Medical Group, based in Shenzhen, is the applicant of record for K254290.

How long did the K254290 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Jan 30, 2026, 30 days later.

← All decisions in January 2026