510(k) · Cleared
ClearedMedcomp Ash 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 May 22, 2002 as substantially equivalent to K972207 (Medcomp, 1998) and 1 other predicate after a 99-day review. Its family tree reaches back 2 generations to 1998. 3 of the 33 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 99 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981994 (1998). 3 ancestors in all, the oldest K972207 (1998). 29 later devices descend from it, 6 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 1 generation backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- This deviceK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- Descendant · cites it directly · 12 of its ownK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK022678 Medcomp SC4Medcomp · 2003
- Descendant · 2 generations on · 10 of its ownK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK040318 Medcomp Split-Cath IIMedcomp · 2005
- Descendant · 2 generations on · 8 of its ownK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003 · cites it directly12descendants
- K022678Medcomp SC4Medcomp · 2003 · cites it directly11descendants
- K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc. · 2003 · 2 generations on10descendants
- K040318Medcomp Split-Cath IIMedcomp · 2005 · cites it directly9descendants
- K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc. · 2005 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −1 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| 0 (this device) | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| +1 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| +1 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| +2 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| +1 | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| +2 | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | 13 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 1 |
| 2016 | 1 | 1 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMSummary page 1…January 28, 2002 Trade Name: Medcomp Ash Split-Cath Il Common Name: Hemodialysis Catheter, Implanted Classification: 78 MSD C.F.R. Section: 876.5540 Predicate Device: K972207 Medcomp Ash Split-Cath K012562 Medcomp 14.5F Double Lumen Hemodialysis Catheter Device Description: The Medcomp Ash Split-Cath… | 1998 |
| * | K012562 | Medcomp 14.5F Double Lumen Hemodialysis CatheterSummary page 1…dcomp Ash Split-Cath Il Common Name: Hemodialysis Catheter, Implanted Classification: 78 MSD C.F.R. Section: 876.5540 Predicate Device: K972207 Medcomp Ash Split-Cath K012562 Medcomp 14.5F Double Lumen Hemodialysis Catheter Device Description: The Medcomp Ash Split-Cath Il is a polyurethane, double lu… | 2002 |
What descends from it? (29)
See all 296 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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030020 (C.R. Bard, Inc., 2003) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K972207.
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 ASH SPLIT-CATH Ii 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020465: Medcomp Ash Split-Cath II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020465
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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