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 / 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 6 other decisions in the tracker over the last 12 months: K262526 (Safety lancet (XL)), K262135 (Lancing device), K262211 (Lancet), K260191 (Safety lancet (XXXVII)).

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