# K061450: Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Aug 4, 2006 after 71 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 K821057 (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)
- K821057: Flow Directed Thermal-Dilution Infusion, Oximetrix, Inc. (1982) Summary page 2.
- K823007: Opticath Heparin Coated, Flow-Direct, Oximetrix, Inc. (1982) Summary page 2.
- K874465: Sorenson Thermo. Flow-Direct Trans Pace Cath/Lead, Abbott Laboratories (1988) Summary page 2.

## Most influential descendants
- K091268: Hospira Latex-Free Critical Care and Advanced Sensor Catheters (2009), 0 descendants of its own

## Indications for use
Hospira Latex-Free Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions. Hospira Latex-Free Critical Care Catheters: Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute bum patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing using a temporary ventricular pacing lead.

Source page: https://510kreport.com/device/K061450
Methodology: https://510kreport.com/methodology