# K061159: Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Jun 26, 2006 after 61 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: 1 generation back to K820674 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 1.

## Indications for use
The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood. The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for 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 probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids

Source page: https://510kreport.com/device/K061159
Methodology: https://510kreport.com/methodology