510(k) · Decided
DecidedCentros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Jun 18, 2014 as substantially equivalent to K092597 (Ash Access Technology, Inc., 2009) after a 26-day review. Its family tree reaches back 8 generations to 1998. 1 of the 18 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 18, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981994 (1998). 16 ancestors in all, the oldest K972207 (1998). 1 later device descends from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 7 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 6 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 5 generations backK022678 Medcomp SC4Medcomp · 2003
- 4 generations backK040318 Medcomp Split-Cath IIMedcomp · 2005
- 3 generations backK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- 2 generations backK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- 1 generation backK092597 Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
- This deviceK141363 Centros Long Term Hemodialysis Catheter, Centrosflo Long Term…Merit Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK151967 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term…Merit Medical Systems, Inc. · 2016 · Recalled (Class I)
Class I recalls in this family
- K151967 Centros Long-Term Hemodialysis Catheter…cites it directly · 2016
Most influential descendants
Showing 1 of 1 · See all- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −7 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −6 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −5 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| −4 | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| −3 | 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 |
| −1 | K092597 | Centros Chronic Hemodialysis Catheter Set | Ash Access Technology, Inc. | 2009 | — |
| 0 (this device) | K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis… | Merit Medical Systems, Inc. | 2014 | — |
| +1 | K151967 | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis… | Merit Medical Systems, Inc. | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092597 | Centros Chronic Hemodialysis Catheter SetSummary page 1…redicate Catheter Device Classification Name: Catheter, Hemodialysis, Implanted Premarket Notification: K092597 Manufacturer: Merit Medical Systems, Inc. Class III Classi… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151967 | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter Class I | 2016 | 0 |
Has anything in its family been recalled? (1 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.
- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K151967 (Merit Medical Systems, Inc., 2016) has gone furthest, with 0 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. 2014, this device’s year, is highlighted.
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 Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter are 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 of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141363: Centros Long Term Hemodialysis Catheter, Centrosflo Long Term 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/K141363
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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