# K022644: Retro Repair Kit, Model PRRK5

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Nov 6, 2002 after 90 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: 3 generations back to K013160 (2002). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes), Spire Biomedical, Inc. (2002) Summary page 1.
- K002902: Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers, The Kendall Company (2001). Our reading of the summary gave K002900, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendall Tandem-Cath”.
- K011015: Catheter Repair Kit with Replacement Connector, Model 5587000, C.R. Bard, Inc. (2001)

## Most influential descendants
- K062435: Repair Kit for Xpresso, Decathlon, and Alta LR Catheters (2006), 0 descendants of its own

## Indications for use
Pourchez RetrO Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.’s Pourchez RetrO catheters.

Source page: https://510kreport.com/device/K022644
Methodology: https://510kreport.com/methodology