Arterial Pressure Monitoring Set/Tray— 510(k) K254278

Clearance details

Applicant

Spectrum Vascular

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

2025-12-30

Decision date

2026-03-25

Decision

Substantially Equivalent

Clearance type

Special

Location

White Plains, NY, US

• K261455 — Arterial Pressure Monitoring Set/Tray2026-06-26
• K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N2026-05-28
• K250751 — DualView Catheter2025-07-17
• K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter2025-01-31
• K242420 — pNOVUS 21 Microcatheter2024-11-12

• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more2025-12-16
• K250724 — Intraosseous Infusion Needles2025-07-30
• K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter2024-11-27

Death

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →