510(k) · Decided
Recalled · Class II · 2025Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Jan 17, 2020 as substantially equivalent to K896252 (Quinton, Inc., 1990) and 4 other predicates after a 147-day review. Its family tree reaches back 9 generations to 2000. 5 of the 29 devices in its family, counting itself, have a Class I recall. It has been recalled 6 times.
- Decided
- Jan 17, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 9 generations to K001901 (2000). 28 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 5 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- 1 generation backK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Recalled (Class I)
- This deviceK192302 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen…Covidien, LLC · 2020
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- 1 generation backK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Recalled (Class I)
- This deviceK192302 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen…Covidien, LLC · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | 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 |
| 0 (this device) | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter… | Covidien, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2002 | 1 | 1 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K896252 | Modified Quinton Single Lumen CatheterSummary page 6…K192302 Page 2 of 4 K896252 ArgyleTM Single Lumen Catheter K943349 MahurkarTM Dual Lumen Catheter K030209 MahurkarTM Dual Lumen High Flow Catheter (Q-PLUS) K… | 1990 |
| * | K943349 | Mahurkar Dual Lumen CatheterSummary page 6…K192302 Page 2 of 4 K896252 ArgyleTM Single Lumen Catheter K943349 MahurkarTM Dual Lumen Catheter K030209 MahurkarTM Dual Lumen High Flow Catheter (Q-PLUS) K020089 MahurkarTM Triple Lumen Catheter… | 1995 |
| * | K030209 | Mahurkar Oplus Catheter, Model 13.5 FRSummary page 6…Page 2 of 4 K896252 ArgyleTM Single Lumen Catheter K943349 MahurkarTM Dual Lumen Catheter K030209 MahurkarTM Dual Lumen High Flow Catheter (Q-PLUS) K020089 MahurkarTM Triple Lumen Catheter K102605 MahurkarTM Triple Lumen High P… | 2003 |
| * | K020089 | Mahurkar Triple Lumen Catheter, 12 FRSummary page 6…Page 2 of 4 K896252 ArgyleTM Single Lumen Catheter K943349 MahurkarTM Dual Lumen Catheter K030209 MahurkarTM Dual Lumen High Flow Catheter (Q-PLUS) K020089 MahurkarTM Triple Lumen Catheter K102605 MahurkarTM Triple Lumen High Pressure Dialysis Catheter Reference Device: K120674 Mahurk… | 2002 |
| * | K102605 | Mahurkar Triple Lumen Dialysis CatheterSummary page 6…ArgyleTM Single Lumen Catheter K943349 MahurkarTM Dual Lumen Catheter K030209 MahurkarTM Dual Lumen High Flow Catheter (Q-PLUS) K020089 MahurkarTM Triple Lumen Catheter K102605 MahurkarTM Triple Lumen High Pressure Dialysis Catheter Reference Device: K120674 MahurkarTM Elite Dual and Triple Lumen Catheter… | 2010 |
| † | K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2025 | Class II | Z-0426-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Class II | Z-0421-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Class II | Z-0422-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Class II | Z-0423-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Class II | Z-0424-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Class II | Z-0425-2026 | Under Investigation by firm | A potential issue with the seal integrity of header bag packaging. |
The 5 latest of 6 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 · Direct predicate · ◆ on the line of descent in FIG. 125 Class I recalls
- K030209Mahurkar Oplus Catheter, Model 13.5 FRThe Kendall Company · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- 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 · 5 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 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 28 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
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…
Read the full statement (104 words)
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.
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/K192302 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192302: Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192302
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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