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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 / May 2026 / K253295

510(k) cleared

Coude Sleeved IC; Coude Plus Sleeved IC

Hollister Incorporated · May 18, 2026 · K253295

FDA cleared the Coude Sleeved IC; Coude Plus Sleeved IC from Hollister Incorporated on May 18, 2026 under K253295, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 29, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hollister Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253295?

K253295 is the FDA 510(k) for Coude Sleeved IC; Coude Plus Sleeved IC, submitted by Hollister Incorporated. FDA's decision date was May 18, 2026, under product code EZD (Catheter, Straight).

Who makes the Coude Sleeved IC; Coude Plus Sleeved IC?

Hollister Incorporated, based in Libertyville, IL, is the applicant of record for K253295.

How long did the K253295 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 18, 2026, 231 days later.

← All decisions in May 2026