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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 / March 2026 / K260191

510(k) cleared

Safety lancet (XXXVII)

Tianjin Huahong Technology Co., Ltd. · Mar 31, 2026 · K260191

FDA cleared the Safety lancet (XXXVII) from Tianjin Huahong Technology Co., Ltd. on Mar 31, 2026 under K260191, a traditional 510(k). The device falls under product code FMK, Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 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 Jan 22, 2026. The decision came 68 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), K252490 (Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)), K253706 (Lancing device (HH-XV-T)).

Questions & Answers

What did FDA clear under K260191?

K260191 is the FDA 510(k) for Safety lancet (XXXVII), submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Mar 31, 2026, under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature).

Who makes the Safety lancet (XXXVII)?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K260191.

How long did the K260191 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Mar 31, 2026, 68 days later.

← All decisions in March 2026

Sources