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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 / October 2025 / K253323

510(k) cleared

Protrieve Sheath

Inari Medical · Oct 29, 2025 · K253323

FDA cleared the Protrieve Sheath from Inari Medical on Oct 29, 2025 under K253323, a special 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Inari Medical has 3 other decisions in the tracker over the last 12 months: K253419 (Triever Duo Catheter), K262538 (Artix MT;Artix Thin-Walled Sheath), K252508 (Intri26 Introducer Sheath).

Questions & Answers

What did FDA clear under K253323?

K253323 is the FDA 510(k) for Protrieve Sheath, submitted by Inari Medical. FDA's decision date was Oct 29, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Protrieve Sheath?

Inari Medical, based in Irvine, CA, is the applicant of record for K253323.

How long did the K253323 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 29, 2025, 29 days later.

← All decisions in October 2025

Sources