510(k) · Decided
Recalled · Class I · 2023Mahurkar Triple Lumen Dialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC, Formerly Registered AS Tyco Healthca · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Dec 22, 2010 as substantially equivalent to K020089 (The Kendall Company, 2002) and 1 other predicate after a 103-day review. Its family tree reaches back 8 generations to 2000. 4 of the 32 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 26 times, including 25 Class I recalls.
- Decided
- Dec 22, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- NIE
- Recalls
- 26 (25 Class I)
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001901 (2000). 24 ancestors in all, the oldest K830256 (1983). 7 later devices descend from it, 4 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- This deviceK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010
- Descendant · cites it directly · 2 of its ownK123292 T3Medcomp · 2013
- Descendant · 2 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
- Descendant · cites it directly · 1 of its ownK120674 Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen…Covidien · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK232945 Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023
- Descendant · cites it directly · 0 of its ownK222170 Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
2012high 2 (2020) · low 0 (2014)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K123292T3Medcomp · 2013 · cites it directly2descendants
- K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 2 generations on1descendant
- K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien · 2012 · cites it directly1descendant
- K232945Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023 · 3 generations on0descendants
- K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| 0 (this device) | K102605 | Mahurkar Triple Lumen Dialysis Catheter | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
| +1 | K123292 | T3 | Medcomp | 2013 | — |
| +2 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
| +1 | K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter | Covidien | 2012 | 2 |
| +3 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023 | — |
| +1 | K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2002 | 1 | 1 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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.
4 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 |
|---|---|---|---|
| * | K020089 | Mahurkar Triple Lumen Catheter, 12 FRSummary page 1…Substantial Equivalence is Claimed: The MAHURKARTM Triple Lumen Dialysis Catheter is substantially equivalent to the predicate MahurkarTM Triple Lumen Dialysis Catheter (K020089) in materials, physical characteristics, and performance characteristics. The expansion of the indications to include Power Injec… | 2002 |
| * | K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterSummary page 1…Injection capabilities through the infusion lumen as well as Central Venous Pressure Monitoring is equivalent to the Bard Power-Trialysis Triple Lumen Dialysis Catheter (K083675). Device Description: The MAHURKARTM Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large l… | 2009 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123292 (Medcomp, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K020089.
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. 2010, this device’s year, is highlighted.
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?
The MAHURKAR™ Triple Lumen Catheter is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102605: Mahurkar Triple Lumen Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102605
Report an extraction error
Are you the manufacturer?
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