# K192302: Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 17, 2020 after 147 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
5 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896252: Modified Quinton Single Lumen Catheter, Quinton, Inc. (1990) Summary page 6.
- K943349: Mahurkar Dual Lumen Catheter, Quinton, Inc. (1995) Summary page 6.
- K030209: Mahurkar Oplus Catheter, Model 13.5 FR, The Kendall Company (2003) Summary page 6.
- K020089: Mahurkar Triple Lumen Catheter, 12 FR, The Kendall Company (2002) Summary page 6.
- K102605: Mahurkar Triple Lumen Dialysis Catheter, Covidien, LLC, Formerly Registered AS Tyco Healthca (2010) Summary page 6.

## Recalls of this device
- Oct 17, 2025 · Class II · Z-0426-2026: A potential issue with the seal integrity of header bag packaging.
- Oct 17, 2025 · Class II · Z-0421-2026: A potential issue with the seal integrity of header bag packaging.
- Oct 17, 2025 · Class II · Z-0422-2026: A potential issue with the seal integrity of header bag packaging.
- Oct 17, 2025 · Class II · Z-0423-2026: A potential issue with the seal integrity of header bag packaging.
- Oct 17, 2025 · Class II · Z-0424-2026: A potential issue with the seal integrity of header bag packaging.
- Oct 17, 2025 · Class II · Z-0425-2026: A potential issue with the seal integrity of header bag packaging.

## Indications for use
The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins. The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis, apheresis, and infusion. The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis, apheresis, and infusion. The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K192302
Methodology: https://510kreport.com/methodology