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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 / March 2026 / K252050

510(k) cleared

Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

Olympus Medical Systems Corporation · Mar 20, 2026 · K252050

FDA cleared the Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D from Olympus Medical Systems Corporation on Mar 20, 2026 under K252050, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jul 1, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K252050?

K252050 is the FDA 510(k) for Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D, submitted by Olympus Medical Systems Corporation. FDA's decision date was Mar 20, 2026, under product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Who makes the Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D?

Olympus Medical Systems Corporation, based in Tokyo, is the applicant of record for K252050.

How long did the K252050 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Mar 20, 2026, 262 days later.

← All decisions in March 2026