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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 / February 2026 / K252490

510(k) cleared

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

Tianjin Huahong Technology Co., Ltd. · Feb 12, 2026 · K252490

FDA cleared the Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) from Tianjin Huahong Technology Co., Ltd. on Feb 12, 2026 under K252490, a special 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 Aug 8, 2025. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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)), K253706 (Lancing device (HH-XV-T)).

Questions & Answers

What did FDA clear under K252490?

K252490 is the FDA 510(k) for Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV), submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Feb 12, 2026, under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature).

Who makes the Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K252490.

How long did the K252490 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Feb 12, 2026, 188 days later.

← All decisions in February 2026

Sources