# K061585: Opticath Central Venous Oximetry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Oct 5, 2006 after 120 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- 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 K820674 (1982). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820674: Opticath, Oximetrix, Inc. (1982) Summary page 1.
- K961552: CVP Polyurethane Catheter, Abbott Laboratories (1997) Summary page 1.
- K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 1.

## Most influential descendants
- K140129: Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter (2014), 0 descendants of its own

## Recalls of this device
- Jan 2, 2020 · Class II · Z-2002-2020: Inability for the guidewire to pass through the needles included with the catheter kits.

## Indications for use
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO 2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice.. The OPTICATH® Central Venous Oximetry Catheter is intended for one-time use.

Source page: https://510kreport.com/device/K061585
Methodology: https://510kreport.com/methodology