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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 / February 2026 / K253568

510(k) cleared

Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR

Fujifilm Corporation · Feb 6, 2026 · K253568

FDA cleared the Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR from Fujifilm Corporation on Feb 6, 2026 under K253568, a special 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 Nov 17, 2025. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

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 K253568?

K253568 is the FDA 510(k) for Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR, submitted by Fujifilm Corporation. FDA's decision date was Feb 6, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K253568.

How long did the K253568 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Feb 6, 2026, 81 days later.

← All decisions in February 2026