# K022620: Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt

- Pathway: 510(k) (Traditional)
- Applicant: Spire Biomedical, Inc.
- Decided: Oct 11, 2002 after 65 days
- Product code: FKA (Dilator, Vessel)
- 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). 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)
- K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter, Spire Biomedical, Inc. (2002)
- K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips, Spire Biomedical, Inc. (2002)
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes), Spire Biomedical, Inc. (2002) Summary page 1.
- K013963: Model 9210 Delivery Catheter, Model 9210, Medtronic Vascular (2002)

## Indications for use
Percutaneous insertion kit designed to provide physicians with a dual wire technique for use with Spire Biomedical, Inc.’s Pourchez XpressOTM and Pourchez RetrOTM catheters only.

Source page: https://510kreport.com/device/K022620
Methodology: https://510kreport.com/methodology