510(k) · Cleared
ClearedDecathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
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 Jan 29, 2008 as substantially equivalent to K032061 (Spire Biomedical, Inc., 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jan 29, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K013160 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 2 generations backK032061 Decathlon Twin Lumen Hemodialysis with Separated Tips, Models…Spire Biomedical, Inc. · 2003 · Recalled
- 1 generation backK042858 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated…Spire Biomedical, Inc. · 2004 · Recalled
- This deviceK073092 Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −2 | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… | Spire Biomedical, Inc. | 2003 | 48 |
| −1 | K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips | Spire Biomedical, Inc. | 2004 | 48 |
| 0 (this device) | K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH…Summary page 1…s Catheter ClassificationName: Catheter, Hemodialysis, Implanted Legally Marketed Device to Which Substantial Equivalence is Claimed: Spire Biomedical, Inc.'s (K032061, K042858) 15.5Fr DecathlonTM Twin Lumen Hemodialysis Catheter with Separated Tips (Staggered split tip configuration, twin lumen… | 2003 |
| * | K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsSummary page 1…r ClassificationName: Catheter, Hemodialysis, Implanted Legally Marketed Device to Which Substantial Equivalence is Claimed: Spire Biomedical, Inc.'s (K032061, K042858) 15.5Fr DecathlonTM Twin Lumen Hemodialysis Catheter with Separated Tips (Staggered split tip configuration, twin lumen proximal… | 2004 |
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 6 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 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. 2008, 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?
Spire Biomedical, Inc.'s DecathlonTM Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter 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/K073092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073092: Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073092
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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