510(k) · Cleared
Recalled · 200814.5 FR Chronic Hemodialysis Catheter with Insertion Stylets Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall · MSD Catheter, Hemodialysis, Implanted
Cleared on Oct 6, 2005 after a 113-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Oct 6, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Maxid 14.5 Fr Chronic Hemodialysis Catheter Named without a submission number | |
| * | — | Palindrome 14.5 Fr Chronic Hemodialysis Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2008 | Not classified | Z-0408-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0409-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0411-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0410-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051584: 14.5 FR Chronic Hemodialysis Catheter with Insertion Stylets Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051584
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026