510(k) · Cleared
ClearedDecathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
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 22, 2008 as substantially equivalent to K060155 (Spire Biomedical, Inc., 2006) after an 82-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 22, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925626 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK925626 Maxima Plus Hollow Fiber OxygenatorMedtronic Vascular · 1993
- 1 generation backK060155 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter…Spire Biomedical, Inc. · 2006 · Recalled
- This deviceK073093 Decathlon Gold 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 |
|---|---|---|---|---|---|
| −2 | K925626 | Maxima Plus Hollow Fiber Oxygenator | Medtronic Vascular | 1993 | — |
| −1 | K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with… | Spire Biomedical, Inc. | 2006 | 47 |
| 0 (this device) | K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSummary page 1…s Catheter ClassificationName: Catheter, Hemodialysis, Implanted Legally Marketed Device to Which Substantial Equivalence is Claimed: Spire Biomedical, Inc.'s (K060155) 15.5Fr DecathlonTM Gold Twin Lumen Hemodialysis Catheter with Separated Tips (Staggered split tip configuration, twin lumen prox… | 2006 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060155.
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 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 clotting is
supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral
vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073093: Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073093
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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