510(k) · Cleared

Cleared

Catheter Repair Kit with Replacement Connector, Model 5587000

K022561510(k) TraditionalCleared Aug 23, 200221-day reviewClass II21 CFR 876.5540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · NFK Kit, Repair, Catheter, Hemodialysis

Cleared on Aug 23, 2002 as substantially equivalent to K011015 (C.R. Bard, Inc., 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.

Decided: Aug 23, 2002
Review: 21 days
Class: Class II
Product code: NFK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011015 (2001). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011015 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2001
This deviceK022561 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002
Descendant · cites it directly · 3 of its ownK030442 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003
Descendant · 2 generations on · 2 of its ownK063446 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
Descendant · 3 generations on · 0 of its ownK101261 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
Descendant · 3 generations on · 0 of its ownK092797 Acute and Chronic Catheter Repair KitKendall · 2009 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003 · cites it directly3descendants
K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006 · 2 generations on2descendants
K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010 · 3 generations on0descendants
K092797Acute and Chronic Catheter Repair KitKendall · 2009 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011015	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard, Inc.	2001	—
0 (this device)	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	—
+2	K063446	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard, Inc.	2006	—
+3	K101261	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard, Inc.	2010	—
+3	K092797	Acute and Chronic Catheter Repair Kit	Kendall	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K022561, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K011015	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard, Inc.	2001	—

Also cleared against K011015: 2 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030442	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard, Inc.	2003	3

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?

Its one ancestor has no recall.
Of its descendants, K030442 (C.R. Bard, Inc., 2003) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K011015.

How does its category compare?

All NFK devices

NFK Kit, Repair, Catheter, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFK

1in 2010

2007high 1 (2009) · low 0 (2007)2026

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

2007high 19 (2024) · low 0 (2008)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	MAUDE reports
2007	0	—	1
2008	0	—	0
2009	1	—	2
2010	1	—	3
2011	0	—	16
2012	0	—	11
2013	0	—	16
2014	0	—	1
2015	0	—	1
2016	0	—	7
2017	0	—	8
2018	0	—	5
2019	0	—	5
2020	0	—	1
2021	0	—	0
2022	0	—	18
2023	0	—	4
2024	0	—	19
2025	0	—	18
2026	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 Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022561: 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/K022561

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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