510(k) · Cleared
Recalled · 2009Medcomp Bio-Flex CS Catheter (CS100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 23, 1998 after a 276-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Feb 23, 1998
- Review
- 276 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 2 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK971925 Medcomp Bio-Flex CS Catheter (CS100)Medical Components, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK022678 Medcomp SC4Medcomp · 2003
- Descendant · cites it directly · 9 of its ownK040318 Medcomp Split-Cath IIMedcomp · 2005
- Descendant · 2 generations on · 7 of its ownK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 6 of its ownK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 2 of its ownK101843 Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K022678Medcomp SC4Medcomp · 2003 · cites it directly11descendants
- K040318Medcomp Split-Cath IIMedcomp · 2005 · cites it directly9descendants
- K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc. · 2007 · 2 generations on7descendants
- K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · 3 generations on6descendants
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971925 | Medcomp Bio-Flex CS Catheter (CS100) | Medical Components, Inc. | 1998 | — |
| +1 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| +1 | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| +2 | K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR… | Ash Access Technology, Inc. | 2007 | 3 |
| +3 | K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2008 | 5 |
| +4 | K101843 | Duramax Chronic Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2010 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2014 | 3 | 1 |
| 2016 | 1 | 1 |
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.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2009 | Not classified | Z-0161-2010 | Employee error | mislabeled as right are actually left |
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?
- Of its descendants, K022678 (Medcomp, 2003) has gone furthest, with 11 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 Bio-Flex™ CS Catheter with Adjustable Cuff is designed for fong term hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Although this catheter may be inserted 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/K971925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971925: Medcomp Bio-Flex CS Catheter (CS100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971925
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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