510(k) · Cleared
Recalled · 200915.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with 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 May 9, 2006 as substantially equivalent to K925626 (Medtronic Vascular, 1993) and 3 other predicates after a 109-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it. It has been recalled 47 times.
- Decided
- May 9, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 47
- Predicates
- 4
Its longest line of descent runs back 1 generation to K925626 (1993). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925626 Maxima Plus Hollow Fiber OxygenatorMedtronic Vascular · 1993
- This deviceK060155 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter…Spire Biomedical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073093 Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK063441 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24…Spire Biomedical, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK063431 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter…Spire Biomedical, Inc. · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…Spire Biomedical, Inc. · 2008 · cites it directly0descendants
- K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc. · 2007 · cites it directly0descendants
- K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925626 | Maxima Plus Hollow Fiber Oxygenator | Medtronic Vascular | 1993 | — |
| 0 (this device) | K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with… | Spire Biomedical, Inc. | 2006 | — |
| +1 | K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
| +1 | K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28… | Spire Biomedical, Inc. | 2007 | 48 |
| +1 | K063431 | 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24… | Spire Biomedical, Inc. | 2007 | 48 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K925626 | Maxima Plus Hollow Fiber OxygenatorSummary page 3…coating has been approved for the following legally marketed devices to which substantial equivalence is claimed: 1. Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K933586) 2. Diametrics Paratrend intravascular blood gas sensor catheter (K970906) 3. Cordis Bx Velocity coronary stent… | 1993 |
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 3…been approved for the following legally marketed devices to which substantial equivalence is claimed: 1. Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K933586) 2. Diametrics Paratrend intravascular blood gas sensor catheter (K970906) 3. Cordis Bx Velocity coronary stent (P900043/S0… | 1994 |
| * | K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus…Summary page 3…l equivalence is claimed: 1. Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K933586) 2. Diametrics Paratrend intravascular blood gas sensor catheter (K970906) 3. Cordis Bx Velocity coronary stent (P900043/S024) Performance Data: A series of physical tests were conducted to demonstr… | 1997 |
| * | P900043/ | BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary ArteriesSummary page 3…ardiopulmonary bypass circuit (K925626 and K933586) 2. Diametrics Paratrend intravascular blood gas sensor catheter (K970906) 3. Cordis Bx Velocity coronary stent (P900043/S024) Performance Data: A series of physical tests were conducted to demonstrate substantial equivalence to our non- treated "Decath… | 2000 |
| * | — | non-treated Decathlon catheter Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24… | 2008 | 0 |
| K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32… | 2007 | 0 |
| K063431 | 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28… | 2007 | 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-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 47 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown,
The ability of the Carmeda® End-Point Bonded heparin coating to reduce dotting is supported by in-vitro and animal testing.
The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.
Catheters longer than 40cm are intended for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060155
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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