510(k) · Cleared
ClearedMahurkar 8 FR Dual Lemen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Sep 13, 1996 after a 317-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Sep 13, 1996
- Review
- 317 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK955002 Mahurkar 8 FR Dual Lemen CatheterQuinton, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK192807 Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) · 2020
- Descendant · 2 generations on · 0 of its ownK250836 14F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955002 | Mahurkar 8 FR Dual Lemen Catheter | Quinton, Inc. | 1996 | — |
| +1 | K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2020 | — |
| +2 | K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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.
Planning a device in MPB? 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? (3)
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 Dual Lumen Catheters Named without a submission number | |
| * | — | Duo-flow Double Lumen Catheter Named without a submission number | |
| * | — | Safe-Dwel Plus Bi-Lumen Catheter Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192807 (Medical Components, Inc. (dba MedComp), 2020) 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?
The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device 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/K955002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955002: Mahurkar 8 FR Dual Lemen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955002
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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