# K261455: Arterial Pressure Monitoring Set/Tray

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Vascular
- Decided: Jun 26, 2026 after 56 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002254 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K254278: Arterial Pressure Monitoring Set/Tray, Spectrum Vascular (2026) Summary page 5.

## Indications for use
The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients. • 2.5 French catheters are intended for patients from birth and older. • 3.0 and 4.0 French catheters are intended for patients aged 1 year and older. • 5.0 French catheters are intended for patients aged 12 years and older.

Source page: https://510kreport.com/device/K261455
Methodology: https://510kreport.com/methodology