# K140129: Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jul 2, 2014 after 167 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 30 ancestors in all.
No later device cites it as a predicate yet.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061585: Opticath Central Venous Oximetry Catheter, Hospira, Inc. (2006) Summary page 1.
- K113277: Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits, Arrow International, Inc. (2012) Summary page 1.

## Indications for use
The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.

Source page: https://510kreport.com/device/K140129
Methodology: https://510kreport.com/methodology