510(k) · Cleared
Recalled · Class II · 2020Hospira Latex-Free Critical Care and Advanced Sensor Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · DQE Catheter, Oximeter, Fiber-Optic
Cleared on Sep 18, 2009 as substantially equivalent to K061450 (Hospira, Inc., 2006) after a 141-day review. Its family tree reaches back 2 generations to 1982. It has been recalled 5 times.
- Decided
- Sep 18, 2009
- Review
- 141 days
- Class
- Class II
- Product code
- DQE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K821057 (1982). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK821057 Flow Directed Thermal-Dilution InfusionOximetrix, Inc. · 1982
- 1 generation backK061450 Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free…Hospira, Inc. · 2006
- This deviceK091268 Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K821057 | Flow Directed Thermal-Dilution Infusion | Oximetrix, Inc. | 1982 | — |
| −1 | K061450 | Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care… | Hospira, Inc. | 2006 | — |
| 0 (this device) | K091268 | Hospira Latex-Free Critical Care and Advanced Sensor Catheters | Hospira, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K061450 | Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care CathetersSummary page 1…ce: A/dvanced Sensor Catheter 6. Predicate Devices: Hospira Critical Care and Advanced Sensor Catheter (K061450) 7. Proposed Device Description: The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2020 | Class II | Z-1999-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
| Jan 2, 2020 | Class II | Z-1997-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
| Jan 2, 2020 | Class II | Z-2001-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
| Jan 2, 2020 | Class II | Z-2000-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
| Jan 2, 2020 | Class II | Z-1998-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 24.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DQE devicesDQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQE
1in 2018
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 20 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 51 |
| 2010 | 0 | — | 0 | 64 |
| 2011 | 1 | — | 0 | 54 |
| 2012 | 0 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 38 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 1 | — | 0 | 68 |
| 2017 | 0 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 38 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 0 | — | 0 | 57 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 0 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 31 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hospira 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 Critical Care Catheters: Indicated for the assessment of hemodynamic status through right atrial, right ventricular,, and pulmonary artery…
Read the full statement (177 words)
Hospira 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 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 form mitral regurgitation;' diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn 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 the placenta; cardiac output determination by thermodilution method; and blood sampling.
Additional indication for Hospira Critical Care Pacing Lead Catheters:
Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091268: Hospira Latex-Free Critical Care and Advanced Sensor Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091268
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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