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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 / June 2026 / K253137

510(k) cleared

FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

Fujifilm Corporation · Jun 16, 2026 · K253137

FDA cleared the FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T from Fujifilm Corporation on Jun 16, 2026 under K253137, 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 Sep 25, 2025. The decision came 264 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 K253137?

K253137 is the FDA 510(k) for FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T, submitted by Fujifilm Corporation. FDA's decision date was Jun 16, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K253137.

How long did the K253137 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 16, 2026, 264 days later.

← All decisions in June 2026