510(k) · Cleared
Recalled · Class I · 2023Mahurkar Triple Lumen Catheter, 12 FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Apr 10, 2002 after a 90-day review. The FDA summary names its predicate without a number. 5 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled 26 times, including 25 Class I recalls.
- Decided
- Apr 10, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NIE
- Recalls
- 26 (25 Class I)
- Predicates
- 0
15 later devices descend from it, 4 citing it directly. 5 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK020089 Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002
- Descendant · cites it directly · 12 of its ownK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK033570 Medcomp T-3Medcomp · 2004
- Descendant · 2 generations on · 2 of its ownK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK123292 T3Medcomp · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
2004high 2 (2015) · low 0 (2005)2026
Class I recalls in this family
- K102605 Mahurkar Triple Lumen Dialysis Cathetercites it directly · 2010
- K143102 Multi-Lumen Acute Hemodialysis Catheter for High…2 generations on · 2015
- K133456 Power-Trialysis Short-Term Dialysis Catheter2 generations on · 2014
- K141531 Power-Trialysis Slim-Cath Short-Term Dialysis…3 generations on · 2015
Most influential descendants
Showing 5 of 15 · See all- K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009 · cites it directly12descendants
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · cites it directly7descendants
- K033570Medcomp T-3Medcomp · 2004 · cites it directly4descendants
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K123292T3Medcomp · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020089 | Mahurkar Triple Lumen Catheter, 12 FR | The Kendall Company | 2002 | — |
| +1 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| +1 | K102605 | Mahurkar Triple Lumen Dialysis Catheter | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | Class I |
| +1 | K033570 | Medcomp T-3 | Medcomp | 2004 | — |
| +2 | K133456 | Power-Trialysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2014 | Class I |
| +2 | K123292 | T3 | Medcomp | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 2 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
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.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NIE device
- #1 K232945 Trio-CT® Triple Lumen Catheter w/ Curved…score 9.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | MAHURKAR® Triple Lumen Catheter for Infusion Named without a submission number | |
| * | — | MAHURKAR® Dual Lumen Catheter Named without a submission number |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2023 | Class I | Z-2377-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2367-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2382-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2386-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2381-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2372-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2370-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2389-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2383-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2369-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2373-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2385-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2378-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2374-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2375-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2376-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2387-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2368-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2391-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2390-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2380-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2388-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2371-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2384-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Jun 28, 2023 | Class I | Z-2379-2023 | Process control | 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, partially or fully, and/or uncured or… |
| Apr 29, 2019 | Class II | Z-1955-2019 | Error in labeling | 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. |
The 5 latest of 26 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K083675 (C.R. Bard, Inc., 2009) has gone furthest, with 12 descendants of its own.
How does its category compare?
All NIE devicesNIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIE
2in 2023
2007high 2 (2015) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NIE
Too few NIE 510(k)s in any year since 2007 to give a median.
Recalls per year · NIE
6in 2025
2007high 6 (2025) · low 0 (2007)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NIE
72in 2025
2007high 125 (2024) · low 0 (2007)2025
MAUDE reports naming product code NIE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 1 | — | 1 | 61 |
| 2020 | 0 | — | 0 | 51 |
| 2021 | 0 | — | 0 | 61 |
| 2022 | 0 | — | 1 (1) | 119 |
| 2023 | 2 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 125 |
| 2025 | 0 | — | 6 | 72 |
| 2026 | 0 | — | 3 (1) | — |
What is it indicated for?
Mahurkar® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020089: Mahurkar Triple Lumen Catheter, 12 FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020089
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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