WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / December 2025 / K250863

510(k) cleared

FUJIFILM Ultrasonic Endoscope EB-710US

Fujifilm Corporation · Dec 12, 2025 · K250863

FDA cleared the FUJIFILM Ultrasonic Endoscope EB-710US from Fujifilm Corporation on Dec 12, 2025 under K250863, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Mar 21, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K262902 (ECHELON Synergy), K261229 (SCENARIA View Phase 6.0), K261283 (APERTO Lucent MRI System), K253836 (FCT iStream Phase 2).

Questions & Answers

What did FDA clear under K250863?

K250863 is the FDA 510(k) for FUJIFILM Ultrasonic Endoscope EB-710US, submitted by Fujifilm Corporation. FDA's decision date was Dec 12, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the FUJIFILM Ultrasonic Endoscope EB-710US?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K250863.

How long did the K250863 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Dec 12, 2025, 266 days later.

← All decisions in December 2025