510(k) · Decided
Recalled · Class I · 2026Centros 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 Apr 4, 2016 as substantially equivalent to K141363 (Merit Medical Systems, Inc., 2014) after a 263-day review. Its family tree reaches back 9 generations to 1998. 1 of the 18 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Apr 4, 2016
- Review
- 263 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981994 (1998). 17 ancestors in all, the oldest K972207 (1998). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 5 generations between
- 3 generations backK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- 2 generations backK092597 Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
- 1 generation backK141363 Centros Long Term Hemodialysis Catheter, Centrosflo Long Term…Merit Medical Systems, Inc. · 2014
- This deviceK151967 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term…Merit Medical Systems, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 8 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 7 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 6 generations backK022678 Medcomp SC4Medcomp · 2003
- 5 generations backK040318 Medcomp Split-Cath IIMedcomp · 2005
- 4 generations backK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- 3 generations backK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- 2 generations backK092597 Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
- 1 generation backK141363 Centros Long Term Hemodialysis Catheter, Centrosflo Long Term…Merit Medical Systems, Inc. · 2014
- This deviceK151967 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term…Merit Medical Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −8 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −7 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −6 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| −5 | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| −4 | 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 |
| −2 | K092597 | Centros Chronic Hemodialysis Catheter Set | Ash Access Technology, Inc. | 2009 | — |
| −1 | K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis… | Merit Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K151967 | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis… | Merit Medical Systems, Inc. | 2016 | — |
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 |
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 12.4 · 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? (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 |
|---|---|---|---|
| * | K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterSummary page 4…Hemodialysis Catheter Predicate Classification Name: Catheter, Hemodialysis, Implanted Device Premarket Notification: K141363 Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a de… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2026 | Class I | Z-1575-2026 | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 17 ancestors have a recall of any class.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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/K151967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151967: 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 4, 2026. https://510kreport.com/device/K151967
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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