# K022570: Medcomp Repair Kit, Model Aspcrpk

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Oct 31, 2002 after 90 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011015 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011015: Catheter Repair Kit with Replacement Connector, Model 5587000, C.R. Bard, Inc. (2001)

## Recalls of this device
- Feb 23, 2018 · Class II · Z-1127-2018: There 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, 2018 · Class II · Z-1123-2018: There 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, 2018 · Class II · Z-1118-2018: There 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, 2018 · Class II · Z-1124-2018: There 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, 2018 · Class II · Z-1126-2018: There 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, 2018 · Class II · Z-1122-2018: There 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, 2018 · Class II · Z-1125-2018: There 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, 2018 · Class II · Z-1119-2018: There 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, 2018 · Class II · Z-1120-2018: There 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.

## Indications for use
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

Source page: https://510kreport.com/device/K022570
Methodology: https://510kreport.com/methodology