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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 / October 2026 / K260468

510(k) cleared

H100Plus Hemoglobin Testing System

Shenzhen Lifotronic Technology Co., Ltd. · Oct 2, 2026 · K260468

FDA cleared the H100Plus Hemoglobin Testing System from Shenzhen Lifotronic Technology Co., Ltd. on Oct 2, 2026 under K260468, a traditional 510(k). The device falls under product code PDJ, Hemoglobin A1c Test System, regulated at 21 CFR 862.1373 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Feb 12, 2026. The decision came 232 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shenzhen Lifotronic Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260468?

K260468 is the FDA 510(k) for H100Plus Hemoglobin Testing System, submitted by Shenzhen Lifotronic Technology Co., Ltd.. FDA's decision date was Oct 2, 2026, under product code PDJ (Hemoglobin A1c Test System).

Who makes the H100Plus Hemoglobin Testing System?

Shenzhen Lifotronic Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260468.

How long did the K260468 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Oct 2, 2026, 232 days later.

← All decisions in October 2026