510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Medcomp Repair Kit, Model Aspcrpk

K022570510(k) TraditionalCleared Oct 31, 200290-day reviewClass II21 CFR 876.5540Recalls 9

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

Medcomp · NFK Kit, Repair, Catheter, Hemodialysis

Cleared on Oct 31, 2002 as substantially equivalent to K011015 (C.R. Bard, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 9 times.

Decided
Oct 31, 2002
Review
90 days
Class
Class II
Product code
NFK
Recalls
9
Predicates
1

Its longest line of descent runs back 1 generation 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. · 2001200020022004
K011015 · Catheter Repair Kit with Replacement Connector, Model 5587000 · C.R. Bard, Inc. · 20010
  1. Root · 1 generation backK011015 Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2001
  2. This deviceK022570 Medcomp Repair Kit, Model AspcrpkMedcomp · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011015Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2001—
0 (this device)K022570Medcomp Repair Kit, Model AspcrpkMedcomp2002—
FIG. 1 — Lineage of K022570, 2001–2002Source: 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
*K011015Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2001—

Also cleared against K011015: 2 other devices →

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
Feb 23, 2018Class IIZ-1127-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1123-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1118-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1124-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1126-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1122-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1125-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1119-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Feb 23, 2018Class IIZ-1120-2018Nonconforming Material/ComponentThere is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 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

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 MEDCOMP REPAIR KIT IS INDICATED FOR USE IN REPLACING DAMAGED FEMALE LUER CONNECTORS, CLAMPS, OR REPAIRING EXTENSIONS WHERE THERE IS A MINIMUM OF 4.5cm VIABLE EXTENSION TUBING.

REPAIRS MEDCOMP CATHETERS: IOF Ash Split CathB XL, IOF Ash Split Catha II, 14F Ash Split CathB, 14F Ash Split CathB XL, 14F Ash Split Catha II, 16F Ash Split CathB II

Indications for use as stated in the FDA summary.

Also cleared against K011015

2 other devices cite the same predicate.

  • K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002
  • K022561Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2002

More from Medcomp

40 FDA decisions under this applicant name. See the company

  • K130889Split Cath RGMedcomp · 2014
  • K123292T3Medcomp · 2013
  • K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
  • K091954Micro-Stick SetMedcomp · 2010
  • K091953Pro-PiccMedcomp · 2009

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/K022570 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022570: Medcomp Repair Kit, Model Aspcrpk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022570

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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