510(k) · Cleared
Recalled · Class I · 2022Mahurkar Oplus Catheter, Model 13.5 FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on May 13, 2003 after a 112-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- May 13, 2003
- Review
- 112 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 4 (1 Class I)
- Predicates
- 0
5 later devices descend from it, 3 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK030209 Mahurkar Oplus Catheter, Model 13.5 FRThe Kendall Company · 2003
- Descendant · cites it directly · 1 of its ownK120674 Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen…Covidien · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK063355 D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK200426 Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation · 2020
- Descendant · cites it directly · 0 of its ownK192302 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen…Covidien, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien · 2012 · cites it directly1descendant
- K063355D-Line Catheter ST, Double Lumen ST; Extra FlowNovosci Corp. · 2007 · cites it directly1descendant
- K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation · 2020 · 2 generations on0descendants
- K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC · 2020 · cites it directly0descendants
- K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030209 | Mahurkar Oplus Catheter, Model 13.5 FR | The Kendall Company | 2003 | — |
| +1 | K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter | Covidien | 2012 | 2 |
| +1 | K063355 | D-Line Catheter ST, Double Lumen ST; Extra Flow | Novosci Corp. | 2007 | — |
| +2 | K200426 | Acute Dual Lumen Hemodialysis Catheter | Health Line International Corporation | 2020 | — |
| +1 | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter… | Covidien, LLC | 2020 | 6 |
| +2 | K102833 | Disposable Hemodialysis Access Catheter Sets | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | — | MAHURKARB Triple Lumen Catheter Named without a submission number | |
| * | — | MAHURKARB Dual Lumen Catheter Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class I | Z-0877-2023 | Process design | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. |
| 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. |
| Dec 2, 2003 | Not classified | Z-0233-04 | Other | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm |
| Dec 2, 2003 | Not classified | Z-0234-04 | Other | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120674 (Covidien, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MAHURKARm QPLUSB Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030209 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030209: Mahurkar Oplus Catheter, Model 13.5 FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030209
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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