510(k) · Cleared
Recalled · Class II · 2012Hospira Cath Lab Convenience Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Dec 22, 2005 as substantially equivalent to K932141 (Abbott Laboratories, 1994) after a 72-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 3 times.
- Decided
- Dec 22, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932141 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK932141 Cardiac Catheterization KitAbbott Laboratories · 1994 · Recalled
- This deviceK052865 Hospira Cath Lab Convenience KitsIcu Medical, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932141 | Cardiac Catheterization Kit | Abbott Laboratories | 1994 | 1 |
| 0 (this device) | K052865 | Hospira Cath Lab Convenience Kits | Icu Medical, Inc. | 2005 | — |
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 DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K932141 | Cardiac Catheterization KitSummary page 2…of Substantial Equivalence The HOSPIRA CathLab Convenience Kits as described in this submission is substantially equivalent to the predicate CARDIAC CATHETERIZATION KIT (K932141) with respect to the following characteristics: Similarities: 1) Both kits have the same intended use. 2) Both kits are asse… | 1994 |
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 |
|---|---|---|---|---|
| Apr 17, 2012 | Class II | Z-2128-2012 | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. |
| Apr 17, 2012 | Class II | Z-2131-2012 | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. |
| Apr 17, 2012 | Class II | Z-2129-2012 | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The HOSPIRA Cath Lab Convenience Kits are intended for use in cardiac catheterization and radiology procedures requiring the use of contrast media. These procedures include right heart studies, venogram and arteriogram. The kit provides the user with a "ready-to-use" set up avoiding the need to acquire / assemble components from various manufacturers. The kit is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052865: Hospira Cath Lab Convenience Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052865
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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