Cleared Traditional

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

K252373 · Spectrum Vascular · General Hospital

Dec 2025

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K252373 is an FDA 510(k) clearance for 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, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on December 16, 2025, 139 days after receiving the submission on July 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number	K252373 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2025
Decision Date	December 16, 2025
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5970