510(k) · Cleared
ClearedSheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spire Biomedical, Inc. · FKA Dilator, Vessel
Cleared on Oct 11, 2002 as substantially equivalent to K013160 (Spire Biomedical, Inc., 2002) and 3 other predicates after a 65-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 11, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- FKA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K013160 (2002). 6 ancestors in all, the oldest K950179 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 2 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 1 generation backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- This deviceK022620 Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36…Spire Biomedical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −2 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| −1 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| 0 (this device) | K022620 | Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and… | Spire Biomedical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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 FKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | 2002 |
| * | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips | 2002 |
| * | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Summary page 1…l Equivalence is Claimed: 1) Spire Biomedical, Inc. Pourchez RetrO and XpressO Twin Lumen Chronic Hemodialysis Catheters with Separated Tips (KO13160, KO21212 & K022000) similar kit accessories used for percutaneous insertion of these catheters. 2) Medtronic Model 9210 Delivery Catheter p… | 2002 |
| * | K013963 | Model 9210 Delivery Catheter, Model 9210 | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 0 years and passes through 1 company; a new generation was cleared every 2 months on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K013160.
How does its category compare?
All FKA devicesFKA Dilator, Vessel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKA
FDA has decided no FKA device since 2007.
Median 510(k) review, days · FKA
Too few FKA 510(k)s in any year since 2007 to give a median.
Recalls per year · FKA
No recall names FKA since 2007.
Adverse event reports per year · FKA
2in 2017
MAUDE reports naming product code FKA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022620: Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022620
Report an extraction error
Are you the manufacturer?
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