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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 / K253235

510(k) cleared

Introcan Safety® Deep Access XL IV Catheter

B.Braun Medical, Inc. · May 15, 2026 · K253235

FDA cleared the Introcan Safety® Deep Access XL IV Catheter from B.Braun Medical, Inc. on May 15, 2026 under K253235, a traditional 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 29, 2025. The decision came 228 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

B.Braun Medical, Inc. has one other decision in the tracker over the last 12 months: K254111 (Irrigation/Urology Sets).

Questions & Answers

What did FDA clear under K253235?

K253235 is the FDA 510(k) for Introcan Safety® Deep Access XL IV Catheter, submitted by B.Braun Medical, Inc.. FDA's decision date was May 15, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the Introcan Safety® Deep Access XL IV Catheter?

B.Braun Medical, Inc., based in Bethlehem, PA, is the applicant of record for K253235.

How long did the K253235 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 15, 2026, 228 days later.

← All decisions in May 2026

Sources