WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 2026 / K260080

510(k) cleared

Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler

Medical Components, Inc. · Oct 9, 2026 · K260080

FDA cleared the Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler from Medical Components, Inc. on Oct 9, 2026 under K260080, a traditional 510(k). The device falls under product code LJS, Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, regulated at 21 CFR 880.5970 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 12, 2026. The decision came 270 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 Medical Components, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260080?

K260080 is the FDA 510(k) for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler, submitted by Medical Components, Inc.. FDA's decision date was Oct 9, 2026, under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).

Who makes the Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler?

Medical Components, Inc., based in Harleysville, PA, is the applicant of record for K260080.

How long did the K260080 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Oct 9, 2026, 270 days later.

← All decisions in October 2026