510(k) · Cleared
ClearedRepair Kit for Xpresso, Decathlon, and Alta LR Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spire Biomedical, Inc. · NFK Kit, Repair, Catheter, Hemodialysis
Cleared on Dec 5, 2006 as substantially equivalent to K022644 (Spire Biomedical, Inc., 2002) after a 106-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Dec 5, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- NFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013160 (2002). 6 ancestors in all, the oldest K002902 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 3 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 2 generations backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 1 generation backK022644 Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002
- This deviceK062435 Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −3 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| −2 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| −1 | K022644 | Retro Repair Kit, Model PRRK5 | Spire Biomedical, Inc. | 2002 | — |
| 0 (this device) | K062435 | Repair Kit for Xpresso, Decathlon, and Alta LR Catheters | Spire Biomedical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 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 NFK? 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? (1)
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 |
|---|---|---|---|
| * | K022644 | Retro Repair Kit, Model PRRK5Summary page 2…STICS COMPARISON TO PREDICATE DEVICES: The Spire BioMedical repair kit for Xpresso®, Decathlon TM , and Alta LRTM catheters is similar to the Pourchez Retro Repair Kit (K022644) in physical characteristics and materials. PERFORMANCE DATA: A series of physical tests were conducted to demonstrate substant… | 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 4 years and passes through 1 company; a new generation was cleared every 4 months on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All NFK devicesNFK Kit, Repair, Catheter, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NFK
Too few NFK 510(k)s in any year since 2007 to give a median.
Recalls per year · NFK
No recall names NFK since 2007.
Adverse event reports per year · NFK
18in 2025
MAUDE reports naming product code NFK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062435: Repair Kit for Xpresso, Decathlon, and Alta LR Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062435
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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