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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 / December 2025 / K252508

510(k) cleared

Intri26 Introducer Sheath

Inari Medical, Inc. · Dec 17, 2025 · K252508

FDA cleared the Intri26 Introducer Sheath from Inari Medical, Inc. on Dec 17, 2025 under K252508, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 8, 2025. The decision came 131 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Inari Medical, Inc. has 3 other decisions in the tracker over the last 12 months: K253419 (Triever Duo Catheter), K262538 (Artix MT;Artix Thin-Walled Sheath), K253323 (Protrieve Sheath).

Questions & Answers

What did FDA clear under K252508?

K252508 is the FDA 510(k) for Intri26 Introducer Sheath, submitted by Inari Medical, Inc.. FDA's decision date was Dec 17, 2025, under product code DYB (Introducer, Catheter).

Who makes the Intri26 Introducer Sheath?

Inari Medical, Inc., based in Irvine, CA, is the applicant of record for K252508.

How long did the K252508 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Dec 17, 2025, 131 days later.

← All decisions in December 2025

Sources