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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 / August 2026 / K260845

510(k) cleared

Huahong Sharps Container (HHR-I, HHR-II)

Tianjin Huahong Technology Co., Ltd. · Aug 5, 2026 · K260845

FDA cleared the Huahong Sharps Container (HHR-I, HHR-II) from Tianjin Huahong Technology Co., Ltd. on Aug 5, 2026 under K260845, a traditional 510(k). The device falls under product code MMK, Container, Sharps, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 16, 2026. The decision came 142 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: K262211 (Lancet), 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 K260845?

K260845 is the FDA 510(k) for Huahong Sharps Container (HHR-I, HHR-II), submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Aug 5, 2026, under product code MMK (Container, Sharps).

Who makes the Huahong Sharps Container (HHR-I, HHR-II)?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K260845.

How long did the K260845 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Aug 5, 2026, 142 days later.

← All decisions in August 2026

Sources