510(k) · Cleared
ClearedMedcomp Split-Cath II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 3, 2005 as substantially equivalent to K020465 (Medcomp, 2002) and 2 other predicates after a 360-day review. Its family tree reaches back 4 generations to 1998. 3 of the 16 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 360 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K981994 (1998). 6 ancestors in all, the oldest K971925 (1998). 9 later devices descend from it, 2 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 3 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 2 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 1 generation backK022678 Medcomp SC4Medcomp · 2003
- This deviceK040318 Medcomp Split-Cath IIMedcomp · 2005
- 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 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −4 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −3 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −2 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −1 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| 0 (this device) | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| +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 | 2 | 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 | 2 | 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 12.4 · 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? (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 |
|---|---|---|---|
| * | K020465 | Medcomp Ash Split-Cath IISummary page 1…ed Classification: MSD C.F.R. Section: 876.5540 C. Predicate Device: K020465 Medcomp Ash Split- Cath II,K971925 Medcomp Bio-… | 2002 |
| * | K971925 | Medcomp Bio-Flex CS Catheter (CS100)Summary page 1…876.5540 C. Predicate Device: K020465 Medcomp Ash Split- Cath II,K971925 Medcomp Bio- Flex CS Cath with Adjustable… | 1998 |
| * | K022678 | Medcomp SC4Summary page 1…Cath II,K971925 Medcomp Bio- Flex CS Cath with Adjustable Cuff and K022678 Medcomp Split-Stream SC4 D. Device Description: The Medcomp Split-Ca… | 2003 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070572 (Ash Access Technology, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K020465.
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® Split-Cath® II is indicated for use in attaining chronic (long-term) vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040318: Medcomp Split-Cath II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040318
Report an extraction error
Are you the manufacturer?
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