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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 / November 2025 / K252889

510(k) cleared

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

Olympus Medical Systems Corporation · Nov 25, 2025 · K252889

FDA cleared the Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) from Olympus Medical Systems Corporation on Nov 25, 2025 under K252889, a traditional 510(k). The device falls under product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories), regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 10, 2025. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

Olympus Medical Systems Corporation 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 K252889?

K252889 is the FDA 510(k) for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M), submitted by Olympus Medical Systems Corporation. FDA's decision date was Nov 25, 2025, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

Who makes the Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

Olympus Medical Systems Corporation, based in Tokyo, is the applicant of record for K252889.

How long did the K252889 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Nov 25, 2025, 76 days later.

← All decisions in November 2025