510(k) · Cleared

Cleared

Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters

K061450510(k) TraditionalCleared Aug 4, 200671-day reviewClass II21 CFR 870.1230

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hospira, Inc. · DQE Catheter, Oximeter, Fiber-Optic

Cleared on Aug 4, 2006 as substantially equivalent to K821057 (Oximetrix, Inc., 1982) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.

Decided: Aug 4, 2006
Review: 71 days
Class: Class II
Product code: DQE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K821057 (1982). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK821057 Flow Directed Thermal-Dilution InfusionOximetrix, Inc. · 1982
This deviceK061450 Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free…Hospira, Inc. · 2006
Descendant · cites it directly · 0 of its ownK091268 Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 2009 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K091268Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K821057	Flow Directed Thermal-Dilution Infusion	Oximetrix, Inc.	1982	—
0 (this device)	K061450	Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care…	Hospira, Inc.	2006	—
+1	K091268	Hospira Latex-Free Critical Care and Advanced Sensor Catheters	Hospira, Inc.	2009	5

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K061450, 1982–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K821057	Flow Directed Thermal-Dilution Infusion Summary page 2 …itical Care and Advanced Sensor Catheters as described in this submission are substantially equivalent to the predicate Flow Directed Thermal-Dilution Infusion Catheter (821057), OptiCath Heparin Coated Flow-Directed Catheter (K823007), and Sorenson Thermo Flow-Directed Transluminal Pacing Catheter (K8744…	Oximetrix, Inc.	1982	—
*	K823007	Opticath Heparin Coated, Flow-Direct Summary page 2 …this submission are substantially equivalent to the predicate Flow Directed Thermal-Dilution Infusion Catheter (821057), OptiCath Heparin Coated Flow-Directed Catheter (K823007), and Sorenson Thermo Flow-Directed Transluminal Pacing Catheter (K874465) with respect to the following characteristics: Simila…	Oximetrix, Inc.	1982	—
*	K874465	Sorenson Thermo. Flow-Direct Trans Pace Cath/Lead Summary page 2 …ed Thermal-Dilution Infusion Catheter (821057), OptiCath Heparin Coated Flow-Directed Catheter (K823007), and Sorenson Thermo Flow-Directed Transluminal Pacing Catheter (K874465) with respect to the following characteristics: Similarities: 1) The catheters have the same intended use and indications for…	Abbott Laboratories	1988	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091268	Hospira Latex-Free Critical Care and Advanced Sensor Catheters	Hospira, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K091268 (Hospira, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQE devices

DQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQE

1in 2018

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQE

Too few DQE 510(k)s in any year since 2007 to give a median.

Recalls per year · DQE

No recall names DQE since 2007.

Adverse event reports per year · DQE

31in 2025

2007high 79 (2012) · low 12 (2008)2025

MAUDE reports naming product code DQE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	20
2008	0	—	12
2009	1	—	51
2010	0	—	64
2011	1	—	54
2012	0	—	79
2013	0	—	58
2014	1	—	38
2015	0	—	58
2016	1	—	68
2017	0	—	47
2018	1	—	38
2019	0	—	63
2020	0	—	39
2021	0	—	39
2022	0	—	57
2023	0	—	48
2024	0	—	47
2025	0	—	31
2026	0	—	—

What is it indicated for?

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…

Read the full statement (181 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061450 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061450: Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061450

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026