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 / February 2026 / K250550

510(k) cleared

FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

Fujifilm Corporation · Feb 17, 2026 · K250550

FDA cleared the FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit from Fujifilm Corporation on Feb 17, 2026 under K250550, a traditional 510(k). The device falls under product code FDS, Gastroscope 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 Feb 25, 2025. The decision came 357 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 K250550?

K250550 is the FDA 510(k) for FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit, submitted by Fujifilm Corporation. FDA's decision date was Feb 17, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K250550.

How long did the K250550 review take?

FDA received the submission on Feb 25, 2025 and issued its decision on Feb 17, 2026, 357 days later.

← All decisions in February 2026