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THE TAPE

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 / July 2026 / K262211

510(k) cleared

Lancet

Tianjin Huahong Technology Co., Ltd. · Jul 22, 2026 · K262211

FDA cleared the Lancet from Tianjin Huahong Technology Co., Ltd. on Jul 22, 2026 under K262211, 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 Jun 30, 2026. The decision came 22 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)), K260191 (Safety lancet (XXXVII)), K252490 (Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)), K253706 (Lancing device (HH-XV-T)).

Questions & Answers

What did FDA clear under K262211?

K262211 is the FDA 510(k) for Lancet, submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Jul 22, 2026, under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Who makes the Lancet?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K262211.

How long did the K262211 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Jul 22, 2026, 22 days later.

← All decisions in July 2026

Sources