510(k) · Cleared
ClearedCatheter Repair Kit with Replacement Connector, Model 5587000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · NFK Kit, Repair, Catheter, Hemodialysis
Cleared on Dec 15, 2006 as substantially equivalent to K030442 (C.R. Bard, Inc., 2003) after a 30-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 15, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- NFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011015 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011015 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2001
- 2 generations backK022561 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002
- 1 generation backK030442 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003
- This deviceK063446 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK101261 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK092797 Acute and Chronic Catheter Repair KitKendall · 2009 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011015 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard, Inc. | 2001 | — |
| −2 | K022561 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard, Inc. | 2002 | — |
| −1 | K030442 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K063446 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard, Inc. | 2006 | — |
| +1 | K101261 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard, Inc. | 2010 | — |
| +1 | K092797 | Acute and Chronic Catheter Repair Kit | Kendall | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K030442 | Catheter Repair Kit with Replacement Connector, Model 5587000Summary page 2…ion tree, the Catheter Repair Kit with Replacement Connector is substantially equivalent to the predicate device, Catheter Repair Kit with Replacement Connector, K030442, concurrence date July 21, 2003. DEPARTMENT OF HEALTH & HUMAN SERVICES P… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101261 (C.R. Bard, Inc., 2010) has gone furthest, with 0 descendants of its own.
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: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Tenn Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* 11 Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063446: Catheter Repair Kit with Replacement Connector, Model 5587000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063446
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