510(k) · Decided
DecidedDuet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on May 28, 2009 as substantially equivalent to K981125 (Medical Components, Inc., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- May 28, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981994 (1998). 8 ancestors in all, the oldest K972207 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 4 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 3 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 2 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- 1 generation backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- This deviceK090528 Duet Long-Term Hemodialysis Catheter System, Duet Long-Term…C.R. Bard, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −4 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −3 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −2 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| −1 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K090528 | Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis… | C.R. Bard, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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 MSD? 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 MSD device
- #1 K241581 Hemodialysis Catheterscore 12.3 · 11 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 |
|---|---|---|---|
| * | K981125 | Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6Summary page 1…Name 510(k) Concurrence Date Medcomp Bio-Flexe Catheter with Cuff Long-Term K981125 26 Feb,1999 Devices Hemodialysis DevicesHe _ _ _ _… | 1999 |
| * | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…Summary page 1…_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Bard Hema~pliC XK Long- K033294 26 Nov, 2003 Term Hemodialysis Catheter Duet MT Catheter System:… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K981125.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, 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 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
What is it indicated for?
The DuetTM Long-Term Hemodialysis Catheter System is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. The catheters may be inserted percutaneously into the internal jugular vein, subclavian or external jugular vein.
To replace Extension Leg Assembly where there is a minimum of 6.0 cm of viable catheter on the Duetm Long-Term Hemodialysis Catheter System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090528: Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090528
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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