# K252373: 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

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Vascular
- Decided: Dec 16, 2025 after 139 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K001901 (2000). 47 ancestors in all.
No later device cites it as a predicate yet.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163452: PICC Maximal Barrier Nursing Kit, Navilyst Medical, Inc. (2017) Summary page 7.

## Indications for use
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg. Maximum Power Injection Flow Rate: • 6F Triple Lumen / 55 cm - 6 mL/sec BioFlo PICC with ENDEXO and PASV Valve Technology The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg. Maximum Power Injection Flow Rate: • 3F Single Lumen/55 cm - 1 mL/sec • 4F Single Lumen/55 cm - 3.5 mL/sec • 5F Single Lumen/55 cm - 5 mL/sec • 5F Dual Lumen/55 cm - 4 mL/sec • 6F Dual Lumen/55 cm - 5 mL/sec • 6F Triple Lumen/55 cm - 6 mL/sec BioFlo PICC with ENDEXO Technology The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg. Maximum Power Injection Flow Rate: • 3F Single Lumen/55 cm - 1 mL/sec • 4F Single Lumen/55 cm - 3.5 mL/sec • 5F Single Lumen/55 cm - 5 mL/sec • 5F Dual Lumen/55 cm - 4 mL/sec • 6F Dual Lumen/55 cm - 5 mL/sec • 6F Triple Lumen/55 cm - 6 mL/sec BioFlo Midline Catheter The BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rate: • 3F Single Lumen/20 cm - 2 mL/sec • 4F Single Lumen/20 cm - 6 mL/sec • 5F Single Lumen/20 cm - 6 mL/sec • 5F Dual Lumen/20 cm - 6 mL/sec Xcela Power Injectable PICC The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg. Maximum Power Injection Flow Rate: • 4F Single Lumen/45 cm - 4 mL/sec • 4F Single Lumen/55 cm - 3.5 mL/sec • 5F Single Lumen/55 cm - 5 mL/sec • 5F Dual Lumen/45 cm - 5 mL/sec • 5F Dual Lumen/55 cm - 4 mL/sec • 6F Dual Lumen/55 cm - 5 mL/sec Xcela PICC with PASV Valve Technology The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg. Xcela Hybrid PICC with PASV Technology The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg. Maximum Power Injection Flow Rate: • 6F Triple Lumen/55 cm - 6 mL/sec

Source page: https://510kreport.com/device/K252373
Methodology: https://510kreport.com/methodology