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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 / February 2026 / K253646

510(k) cleared

Single Use Distal Cover MAJ-2315 (MAJ-2315)

Olympus Medical Systems Corp. · Feb 22, 2026 · K253646

FDA cleared the Single Use Distal Cover MAJ-2315 (MAJ-2315) from Olympus Medical Systems Corp. on Feb 22, 2026 under K253646, a traditional 510(k). The device falls under product code FDT, Duodenoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 20, 2025. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Olympus Medical Systems Corp. has 8 other decisions in the tracker over the last 12 months: K262079 (4K Camera Head OLYMPUS CH-S700-08-LB), K260401 (EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)), K260824 (Gastrointestinal Videoscope Olympus GIF-2T1500), K260856 (Disposable Distal Attachment D-201-13404).

Questions & Answers

What did FDA clear under K253646?

K253646 is the FDA 510(k) for Single Use Distal Cover MAJ-2315 (MAJ-2315), submitted by Olympus Medical Systems Corp.. FDA's decision date was Feb 22, 2026, under product code FDT (Duodenoscope And Accessories, Flexible/Rigid).

Who makes the Single Use Distal Cover MAJ-2315 (MAJ-2315)?

Olympus Medical Systems Corp., based in Hachioji-Shi, is the applicant of record for K253646.

How long did the K253646 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Feb 22, 2026, 94 days later.

← All decisions in February 2026