# K020089: Mahurkar Triple Lumen Catheter, 12 FR

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company
- Decided: Apr 10, 2002 after 90 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 26 (25 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
5 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAHURKAR® Triple Lumen Catheter for Infusion: named in the summary without a submission number
- (no number) MAHURKAR® Dual Lumen Catheter: named in the summary without a submission number

## Most influential descendants
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter (2009), 12 descendants of its own
- K102605: Mahurkar Triple Lumen Dialysis Catheter (2010), 7 descendants of its own
- K033570: Medcomp T-3 (2004), 4 descendants of its own
- K133456: Power-Trialysis Short-Term Dialysis Catheter (2014), 2 descendants of its own
- K123292: T3 (2013), 2 descendants of its own

## Recalls of this device
- Jun 28, 2023 · Class I · Z-2377-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2367-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2382-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2386-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2381-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2372-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2370-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2389-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2383-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2369-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2373-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2385-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2378-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2374-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2375-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2376-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2387-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2368-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2391-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2390-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2380-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2388-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2371-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2384-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Jun 28, 2023 · Class I · Z-2379-2023: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, par
- Apr 29, 2019 · Class II · Z-1955-2019: The 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.

## Indications for use
Mahurkar® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

Source page: https://510kreport.com/device/K020089
Methodology: https://510kreport.com/methodology