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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 / K262985

510(k) cleared

Medical Monitor (32MD08WC)

Lg Electronics.Inc · Oct 2, 2026 · K262985

FDA cleared the Medical Monitor (32MD08WC) from Lg Electronics.Inc on Oct 2, 2026 under K262985, a traditional 510(k). The device falls under product code PGY, Display, Diagnostic Radiology, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 27, 2026. The decision came 36 days later, inside the 90 FDA-day goal for a 510(k).

Lg Electronics.Inc has 2 other decisions in the tracker over the last 12 months: K261614 (LED LCD Monitor (OEV-271H)), K261213 (Medical Monitor (40HT513D)).

Questions & Answers

What did FDA clear under K262985?

K262985 is the FDA 510(k) for Medical Monitor (32MD08WC), submitted by Lg Electronics.Inc. FDA's decision date was Oct 2, 2026, under product code PGY (Display, Diagnostic Radiology).

Who makes the Medical Monitor (32MD08WC)?

Lg Electronics.Inc, based in Gumi-Si, is the applicant of record for K262985.

How long did the K262985 review take?

FDA received the submission on Aug 27, 2026 and issued its decision on Oct 2, 2026, 36 days later.

← All decisions in October 2026

Sources