510(k) Report

510(k) · Cleared

Cleared

Catheter Repair Kit with Replacement Connector, Model 5587000

K011015510(k) TraditionalCleared Jun 22, 200179-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 Jun 22, 2001 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Jun 22, 2001
Review
79 days
Class
Class II
Product code
NFK
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2003: 1 descendant cleared2006: 2 descendants cleared2010: 1 descendant cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK011015 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2001
  2. Descendant · cites it directly · 4 of its ownK022561 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002
  3. Descendant · 2 generations on · 3 of its ownK030442 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003
  4. Descendant · 3 generations on · 2 of its ownK063446 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
  5. Descendant · cites it directly · 1 of its ownK022644 Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002
  6. Descendant · 4 generations on · 0 of its ownK101261 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12006: 22009: 12010: 1
2002high 3 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002 · cites it directly4descendants
  • K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003 · 2 generations on3descendants
  • K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006 · 3 generations on2descendants
  • K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002 · cites it directly1descendant
  • K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011015Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2001—
+1K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2002—
+2K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2003—
+3K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2006—
+1K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.2002—
+4K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200620
200910
201010
FIG. 1 — Lineage of K011015, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.20024
K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.20021
K022570Medcomp Repair Kit, Model AspcrpkMedcomp20020

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?

  • Of its descendants, K022561 (C.R. Bard, Inc., 2002) has gone furthest, with 4 descendants of its own.

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

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—

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

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  • 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

  • K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
  • 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

https://510kreport.com/device/K011015 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011015: 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 4, 2026. https://510kreport.com/device/K011015

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026