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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 / K254030

510(k) cleared

cCeLL405

VPIX Medical, Inc. · Oct 2, 2026 · K254030

FDA cleared the cCeLL405 from VPIX Medical, Inc. on Oct 2, 2026 under K254030, a traditional 510(k). The device falls under product code QFX, Diagnostic Neurosurgical Microscope Filter, regulated at 21 CFR 882.4950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 16, 2025. The decision came 290 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

VPIX Medical, Inc. has one other decision in the tracker over the last 12 months: K251852 (cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)).

Questions & Answers

What did FDA clear under K254030?

K254030 is the FDA 510(k) for cCeLL405, submitted by VPIX Medical, Inc.. FDA's decision date was Oct 2, 2026, under product code QFX (Diagnostic Neurosurgical Microscope Filter).

Who makes the cCeLL405?

VPIX Medical, Inc., based in Daejeon, is the applicant of record for K254030.

How long did the K254030 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Oct 2, 2026, 290 days later.

← All decisions in October 2026

Sources