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The Tracker / August 2026 / K262135

510(k) cleared

Lancing device

Tianjin Huahong Technology Co., Ltd. · Aug 18, 2026 · K262135

FDA cleared the Lancing device from Tianjin Huahong Technology Co., Ltd. on Aug 18, 2026 under K262135, a traditional 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 25, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

Tianjin Huahong Technology Co., Ltd. has 5 other decisions in the tracker over the last 12 months: K260845 (Huahong Sharps Container (HHR-I, HHR-II)), K262211 (Lancet), K260191 (Safety lancet (XXXVII)), K252490 (Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)).

Questions & Answers

What did FDA clear under K262135?

K262135 is the FDA 510(k) for Lancing device, submitted by Tianjin Huahong Technology Co., Ltd.. FDA's decision date was Aug 18, 2026, under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Who makes the Lancing device?

Tianjin Huahong Technology Co., Ltd., based in Tianjin, is the applicant of record for K262135.

How long did the K262135 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Aug 18, 2026, 54 days later.

← All decisions in August 2026

Sources