FDA cleared the BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology from Spectrum Vascular on Dec 16, 2025 under K252373, 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 Jul 30, 2025. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Spectrum Vascular has 3 other decisions in the tracker over the last 12 months: K260165 (Unimpregnated Central Venous Catheter), K261455 (Arterial Pressure Monitoring Set/Tray), K254278 (Arterial Pressure Monitoring Set/Tray).
Questions & Answers
What did FDA clear under K252373?
K252373 is the FDA 510(k) for BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology, submitted by Spectrum Vascular. FDA's decision date was Dec 16, 2025, under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).
Who makes the BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology?
Spectrum Vascular, based in White Plains, NY, is the applicant of record for K252373.
How long did the K252373 review take?
FDA received the submission on Jul 30, 2025 and issued its decision on Dec 16, 2025, 139 days later.