WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 6 other decisions in the tracker over the last 12 months: K262526 (Safety lancet (XL)), K262135 (Lancing device), K260845 (Huahong Sharps Container (HHR-I, HHR-II)), K260191 (Safety lancet (XXXVII)).

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