# K180846: Arterial Pressure Monitoring Set/Tray

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 19, 2018 after 261 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002254 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002254: Cook Pressure Monitoring Catheter, Cook, Inc. (2001) Summary page 4.

## Most influential descendants
- K254278: Arterial Pressure Monitoring Set/Tray (2026), 1 descendant of its own
- K261455: Arterial Pressure Monitoring Set/Tray (2026), 0 descendants of its own

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1778-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

## 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 1 year and older

Source page: https://510kreport.com/device/K180846
Methodology: https://510kreport.com/methodology