510(k) Report

510(k) · Decided

Recalled · Class II · 2019

Acute and Chronic Catheter Repair Kit

K092797510(k) TraditionalDecided Nov 19, 200969-day reviewClass II21 CFR 876.5540Recalls 1

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

Kendall · NFK Kit, Repair, Catheter, Hemodialysis

Cleared on Nov 19, 2009 as substantially equivalent to K063446 (C.R. Bard, Inc., 2006) after a 69-day review. Its family tree reaches back 4 generations to 2001. It has been recalled once.

Decided
Nov 19, 2009
Review
69 days
Class
Class II
Product code
NFK
Recalls
1
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. · 2006200020022004200620082010
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 deviceK092797 Acute and Chronic Catheter Repair KitKendall · 2009
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)K092797Acute and Chronic Catheter Repair KitKendall2009—
FIG. 1 — Lineage of K092797, 2001–2009Source: 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 1
…tial Equivalence is Claimed: The CovidienTm Acute and Chronic Catheter Repair kit is substantially equivalent to the Bard Catheter Repair Kit with Replacement Connector (K063446) in intended use, design, and repair methods. Device Description: The CovidienTm Acute and Chronic Catheter Repair Kit is intend…
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)

Recalls of this device

DateClassRecallRoot causeReason
Apr 29, 2019Class IIZ-1955-2019Error in labelingThe priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.9 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. 2009, 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?

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: · Palindrome TM Chronic Care Catheters *…

Read the full statement (175 words)

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include:

· Palindrome TM Chronic Care Catheters

* Palindrome TM EmeraldTM Chronic Care Catheters

• Palindrome TM RubyTM Chronic Care Catheters

* PalindromeTM SapphireTM Chronic Care Catheters

* MAHURKAR m * MaxidTM Chronic Care Catheters

* MAHURKARTm* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters

* MAHURKARTm* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters

MAHURKARTm* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters

* MAHURKARTm* 11.5 Fr. (3:83mm) Dual Lumen Acute Care Catheters

* MAHURKARTM* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters

* MAHURKARTM* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

Indications for use as stated in the FDA summary.

Also cleared against K063446

1 other device cites the same predicate.

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

More from Kendall

12 FDA decisions under this applicant name. See the company

  • K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)Kendall · 200624 recalls
  • K060972Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Kendall · 200638 recalls
  • K053410Gientriport with Universal Single Lumen AdaptorKendall · 2006
  • K05158414.5 FR Chronic Hemodialysis Catheter with Insertion Stylets AccessoryKendall · 20054 recalls
  • K043272Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipKendall · 2004

Recent decisions in NFK

The NFK category page

  • K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
  • 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/K092797 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092797: Acute and Chronic Catheter Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092797

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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