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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 / August 2026 / K253795

510(k) cleared

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

Menicon Co, Ltd. · Aug 13, 2026 · K253795

FDA cleared the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution from Menicon Co, Ltd. on Aug 13, 2026 under K253795, a traditional 510(k). The device falls under product code LPN, Accessories, Soft Lens Products, regulated at 21 CFR 886.5928 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Nov 28, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Menicon Co, Ltd. has one other decision in the tracker over the last 12 months: K262495 (Miru 1day UpSide (midafilcon A)).

Questions & Answers

What did FDA clear under K253795?

K253795 is the FDA 510(k) for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution, submitted by Menicon Co, Ltd.. FDA's decision date was Aug 13, 2026, under product code LPN (Accessories, Soft Lens Products).

Who makes the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution?

Menicon Co, Ltd., based in Nagoya, is the applicant of record for K253795.

How long did the K253795 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 13, 2026, 258 days later.

← All decisions in August 2026

Sources