# Spectrum Vascular

- Location (FDA's records): White Plains, NY
- FDA decisions: 6 (2024–2026): 6 510(k) clearances
- Product codes: FOZ (2), DQO (2), FMI (1), LJS (1)
- 510(k) review time since 2016: median 141 days, against 156 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 4 (https://510kreport.com/company/cook)
- Cook Advanced Technologies: 1 (https://510kreport.com/company/cook-advanced-technologies)
- Navilyst Medical, Inc.: 1 (https://510kreport.com/company/navilyst-medical)

## Its most-cited devices
- K254278: Arterial Pressure Monitoring Set/Tray (2026), cited by 1

## Recent decisions
- K260165: Unimpregnated Central Venous Catheter (Aug 10, 2026)
- K261455: Arterial Pressure Monitoring Set/Tray (Jun 26, 2026)
- K254278: Arterial Pressure Monitoring Set/Tray (Mar 25, 2026)
- 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 (Dec 16, 2025)
- K250724: Intraosseous Infusion Needles (Jul 30, 2025)
- K241115: SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (Nov 27, 2024)

Source page: https://510kreport.com/company/spectrum-vascular