510(k) · Decided
Decided15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · MSD Catheter, Hemodialysis, Implanted
Cleared on Jul 29, 2004 as substantially equivalent to K010306 (Medcomp, 2001) and 2 other predicates after a 104-day review. Its family tree reaches back 3 generations to 1998. 3 of the 15 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jul 29, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K972207 (1998). 6 ancestors in all. 8 later devices descend from it, 1 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
- 2 generations backK994105 Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32…Medical Components, Inc. · 2001 · Recalled
- 1 generation backK030502 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp · 2003 · Recalled
- This deviceK040992 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp · 2004
- Descendant · cites it directly · 7 of its ownK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 2 of its ownK101843 Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK092597 Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK141363 Centros Long Term Hemodialysis Catheter, Centrosflo Long Term…Merit Medical Systems, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc. · 2007 · cites it directly7descendants
- K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · 2 generations on6descendants
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · 3 generations on2descendants
- K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009 · 2 generations on2descendants
- K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM | Medcomp | 1998 | — |
| −2 | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Medical Components, Inc. | 2001 | 2 |
| −1 | K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 | Medcomp | 2003 | 2 |
| 0 (this device) | K040992 | 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706 | Medcomp | 2004 | — |
| +1 | K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR… | Ash Access Technology, Inc. | 2007 | 3 |
| +2 | K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2008 | 5 |
| +3 | K101843 | Duramax Chronic Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2010 | Class I |
| +2 | K092597 | Centros Chronic Hemodialysis Catheter Set | Ash Access Technology, Inc. | 2009 | — |
| +3 | K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis… | Merit Medical Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
| 2014 | 2 | 1 |
| 2016 | 1 | 1 |
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.
3 devices in this family have a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K010306 | Medcomp Excell Split Tip CatheterSummary page 1…anted Classification: 78 MSD C.F.R. Section: 876.5540 C. Predicate Device: K010306 ExcellITM Split-Tip Catheter K012562 14.5F7 Double Lumen Hemodialysis… | 2001 |
| * | K012562 | Medcomp 14.5F Double Lumen Hemodialysis CatheterSummary page 1…876.5540 C. Predicate Device: K010306 ExcellITM Split-Tip Catheter K012562 14.5F7 Double Lumen Hemodialysis Catheter… | 2002 |
| * | K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Summary page 1…K012562 14.5F7 Double Lumen Hemodialysis Catheter K030502 14S5F x 55cm Hemo-FIow Tm Double Lumen Catheter 0. Device Description: T… | 2003 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM… | 2007 | 7 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K070572 (Ash Access Technology, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K010306.
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 MEDCOMP EXCELLTM SPLIT-TIP CATHETER IS INDICATED FOR USE IN ATTAINING LONG TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN.
ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED.
CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040992: 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040992
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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