# K062435: Repair Kit for Xpresso, Decathlon, and Alta LR Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Dec 5, 2006 after 106 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K013160 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022644: Retro Repair Kit, Model PRRK5, Spire Biomedical, Inc. (2002) Summary page 2.

## Indications for use
To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon TM, & Alta LRTM catheters.

Source page: https://510kreport.com/device/K062435
Methodology: https://510kreport.com/methodology