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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 / July 2026 / K261614

510(k) cleared

LED LCD Monitor (OEV-271H)

Lg Electronics.Inc · Jul 17, 2026 · K261614

FDA cleared the LED LCD Monitor (OEV-271H) from Lg Electronics.Inc on Jul 17, 2026 under K261614, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 15, 2026. The decision came 63 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: K262985 (Medical Monitor (32MD08WC)), K261213 (Medical Monitor (40HT513D)).

Questions & Answers

What did FDA clear under K261614?

K261614 is the FDA 510(k) for LED LCD Monitor (OEV-271H), submitted by Lg Electronics.Inc. FDA's decision date was Jul 17, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the LED LCD Monitor (OEV-271H)?

Lg Electronics.Inc, based in Gumi-Si, is the applicant of record for K261614.

How long did the K261614 review take?

FDA received the submission on May 15, 2026 and issued its decision on Jul 17, 2026, 63 days later.

← All decisions in July 2026

Sources