510(k) · Cleared
Recalled · 200955CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spire Biomedical, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Dec 3, 2004 as substantially equivalent to K032061 (Spire Biomedical, Inc., 2003) after a 49-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it. It has been recalled 48 times.
- Decided
- Dec 3, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 48
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013160 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 1 generation backK032061 Decathlon Twin Lumen Hemodialysis with Separated Tips, Models…Spire Biomedical, Inc. · 2003 · Recalled
- This deviceK042858 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated…Spire Biomedical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK073092 Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24…Spire Biomedical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −1 | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… | Spire Biomedical, Inc. | 2003 | 48 |
| 0 (this device) | K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips | Spire Biomedical, Inc. | 2004 | — |
| +1 | K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 12.4 · 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? (1)
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 |
|---|---|---|---|
| * | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH…Summary page 1…ted Devices to Which Substantial Equivalence is Claimed: 1) Spire Biomedical, In.-. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061. Device Description: 55cm 15.5Fr DecathlonTM carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24… | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2009 | Not classified | Z-0288-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0289-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0290-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0299-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0301-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0302-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0304-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0306-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0309-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0311-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0312-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0294-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0295-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0296-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0297-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0300-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0303-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0307-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0308-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0314-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0316-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0317-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0318-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0319-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0321-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0330-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0291-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0292-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0293-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0298-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0305-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0310-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0313-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0315-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0320-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0322-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0323-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0324-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0325-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0327-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0328-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0332-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0334-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0335-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0329-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0331-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0333-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0326-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
The 5 latest of 48 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K073092 (Spire Biomedical, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032061.
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
2007high 8 (2014) · low 0 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
2007high 246 (2014) · low 70 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
2007high 49 (2009) · low 0 (2007)2026
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
2007high 1,054 (2025) · low 118 (2007)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 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042858: 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042858
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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