510(k) · Cleared
ClearedMedcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM
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 23, 1998 after a 256-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.
- Decided
- Feb 23, 1998
- Review
- 256 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 5 citing it directly. 4 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
- Descendant · cites it directly · 29 of its ownK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- Descendant · cites it directly · 20 of its ownK994105 Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32…Medical Components, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 13 of its ownK030502 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp · 2003 · Recalled
- Descendant · 2 generations on · 12 of its ownK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- Descendant · 2 generations on · 11 of its ownK022678 Medcomp SC4Medcomp · 2003
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K020465Medcomp Ash Split-Cath IIMedcomp · 2002 · cites it directly29descendants
- K994105Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40Medical Components, Inc. · 2001 · cites it directly20descendants
- K03050214.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp · 2003 · 2 generations on13descendants
- K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003 · 2 generations on12descendants
- K022678Medcomp SC4Medcomp · 2003 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM | Medcomp | 1998 | — |
| +1 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| +1 | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Medical Components, Inc. | 2001 | 2 |
| +2 | K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 | Medcomp | 2003 | 2 |
| +2 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| +2 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 1 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 1 |
| 2016 | 2 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (49)
See all 495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020465 | Medcomp Ash Split-Cath II | 2002 | 29 |
| K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | 2001 | 20 |
| K013162 | 14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM… | 2001 | 5 |
| K011916 | Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45… | 2001 | 1 |
| K011576 | Medcomp Ash Split | 2001 | 0 |
Has anything in its family been recalled? (4 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.
- K090148Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- 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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020465 (Medcomp, 2002) has gone furthest, with 29 descendants of its own.
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™ Double Lumen Catheter is designed for chronic hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be mserted into the subclavian vein, the internal jugular is the preferred site
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972207 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972207
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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