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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262526

510(k) cleared

Safety lancet (XL)

Tianjin Huahong Technology Co., Ltd. · Sep 13, 2026 · K262526

FDA cleared the Safety lancet (XL) from Tianjin Huahong Technology Co., Ltd. on Sep 13, 2026 under K262526, 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 Jul 22, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

Tianjin Huahong Technology Co., Ltd. has 6 other decisions in the tracker over the last 12 months: K262135 (Lancing device), K260845 (Huahong Sharps Container (HHR-I, HHR-II)), K262211 (Lancet), K260191 (Safety lancet (XXXVII)).

Questions & Answers

What did FDA clear under K262526?

K262526 is the FDA 510(k) for Safety lancet (XL), submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Sep 13, 2026, under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature).

Who makes the Safety lancet (XL)?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K262526.

How long did the K262526 review take?

FDA received the submission on Jul 22, 2026 and issued its decision on Sep 13, 2026, 53 days later.

← All decisions in September 2026

Sources