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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 / K253706

510(k) cleared

Lancing device (HH-XV-T)

Tianjin Huahong Technology Co., Ltd. · Dec 9, 2025 · K253706

FDA cleared the Lancing device (HH-XV-T) from Tianjin Huahong Technology Co., Ltd. on Dec 9, 2025 under K253706, a special 510(k). The device falls under product code QRL, Multiple Use Blood Lancet For Single Patient Use Only, regulated at 21 CFR 878.4850 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 24, 2025. The decision came 15 days later, inside the 90 FDA-day goal for a 510(k).

Tianjin Huahong Technology Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K260845 (Huahong Sharps Container (HHR-I, HHR-II)), K262211 (Lancet), K260191 (Safety lancet (XXXVII)), K252490 (Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)).

Questions & Answers

What did FDA clear under K253706?

K253706 is the FDA 510(k) for Lancing device (HH-XV-T), submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Dec 9, 2025, under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Who makes the Lancing device (HH-XV-T)?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K253706.

How long did the K253706 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 9, 2025, 15 days later.

← All decisions in December 2025

Sources