510(k) · Cleared
ClearedVascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Sep 3, 1998 after an 87-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 of the 42 devices in its family, counting itself, have a Class I recall. 41 later devices descend from it.
- Decided
- Sep 3, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
41 later devices descend from it, 2 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- This deviceK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- Descendant · cites it directly · 38 of its ownK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- Descendant · 2 generations on · 29 of its ownK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 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 · 3 generations on · 12 of its ownK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- Descendant · 3 generations on · 11 of its ownK022678 Medcomp SC4Medcomp · 2003
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 41 · See all- K012562Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002 · cites it directly38descendants
- K020465Medcomp Ash Split-Cath IIMedcomp · 2002 · 2 generations on29descendants
- 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 · 3 generations on12descendants
- K022678Medcomp SC4Medcomp · 2003 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| +2 | K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 | Medcomp | 2003 | 2 |
| +3 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| +3 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 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 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K8714 | Vas-Cath Soft-Cell Catheter Number could not be read Summary page 2…apheresis therapy via the jugular or subclavian vein. 6. Tcchnological Characteristics Characteristic Yas-Cath Opti-Flow Catheter I‘r e Yas-Cath Soft-Cell Catheter (K871 4) Shape of arterial/venous lumens Shaft diameter 15 Fronch 12.5 Fronch Materials polyurethane body and extensions, polyurethane… |
What descends from it? (41)
See all 412 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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012562 (Medical Components, Inc., 2002) has gone furthest, with 38 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 Opti-Flow Dual Lumen Catheter is indicated for use in attaining short
term or long term vascular access for hemodialysis, hemoperfusion or
apheresis therapy via the jugular or subclavian vein.
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/K981994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981994: Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981994
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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