# K052865: Hospira Cath Lab Convenience Kits

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Dec 22, 2005 after 72 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932141 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932141: Cardiac Catheterization Kit, Abbott Laboratories (1994) Summary page 2.

## Recalls of this device
- Apr 17, 2012 · Class II · Z-2128-2012: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K052865
Methodology: https://510kreport.com/methodology