510(k) Report

510(k) · Cleared

Cleared

Catheter Repair Kit with Replacement Connector, Model 5587000

K101261510(k) TraditionalCleared Jul 29, 201085-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 Jul 29, 2010 as substantially equivalent to K063446 (C.R. Bard, Inc., 2006) after an 85-day review. Its family tree reaches back 4 generations to 2001.

Decided
Jul 29, 2010
Review
85 days
Class
Class II
Product code
NFK
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K011015 (2001). No later device cites it as a predicate yet.

K011015 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2001K022561 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2002K030442 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2003K063446 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 20062000200220042006200820102012
K063446 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2006K030442 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2003K022561 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 2002K011015 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 20010
  1. Root · 4 generations backK011015 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2001
  2. 3 generations backK022561 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002
  3. 2 generations backK030442 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003
  4. 1 generation backK063446 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
  5. This deviceK101261 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011015Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2001—
−3K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2002—
−2K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2003—
−1K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2006—
0 (this device)K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2010—
FIG. 1 — Lineage of K101261, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

TypeNumberDeviceApplicantDecidedRecalls
*K063446Catheter Repair Kit with Replacement Connector, Model 5587000
Summary page 2
…f operation and indications for use to the current commercially available Catheter Repair Kit with Replacement Connector (K063446). t0 DEPARTMENT OF HEALTH & HUMAN SERVICES…
C.R. Bard, Inc.2006—

Also cleared against K063446: 1 other device →

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 9 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K063446.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · NFK

1in 2010

2009: 12010: 1
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

2007: 12009: 22010: 32011: 162012: 112013: 162014: 12015: 12016: 72017: 82018: 52019: 52020: 12022: 182023: 42024: 192025: 18
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20091—02
20101—03
20110—016
20120—011
20130—016
20140—01
20150—01
20160—07
20170—08
20180—05
20190—05
20200—01
20210—00
20220—018
20230—04
20240—019
20250—018
20260—0—

What is it indicated for?

To replace: Cracked or bmken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumnen Catheter,

Indications for use as stated in the FDA summary.

Also cleared against K063446

1 other device cites the same predicate.

  • K092797Acute and Chronic Catheter Repair KitKendall · 20091 recall

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in NFK

The NFK category page

  • K092797Acute and Chronic Catheter Repair KitKendall · 20091 recall
  • K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006
  • K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003
  • K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002

https://510kreport.com/device/K101261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101261: 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/K101261

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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