510(k) · Decided
Recalled · Class II · 2020NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marvao Medical Devices, Ltd. · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 8, 2018 as substantially equivalent to K161026 (Marvao Medical Devices, Ltd., 2016) and 1 other predicate after a 55-day review. Its family tree reaches back 13 generations to 2000. 2 of the 34 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Feb 8, 2018
- Review
- 55 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 13 generations to K001901 (2000). 33 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK133796 Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite…Marvao Medical Devices, Ltd. · 2014
- 2 generations backK140492 Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014
- 1 generation backK161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm…Marvao Medical Devices, Ltd. · 2016
- This deviceK173805 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use…Marvao Medical Devices, Ltd. · 2018
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 8 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 7 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 6 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 5 generations backK110627 Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd. · 2011
- 4 generations backK121933 Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd. · 2013
- 3 generations backK133796 Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite…Marvao Medical Devices, Ltd. · 2014
- 2 generations backK140492 Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014
- 1 generation backK161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm…Marvao Medical Devices, Ltd. · 2016
- This deviceK173805 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use…Marvao Medical Devices, Ltd. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −8 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −7 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −6 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −5 | K110627 | Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter | Marvao Medical Devices, Ltd. | 2011 | — |
| −4 | K121933 | Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD… | Marvao Medical Devices, Ltd. | 2013 | — |
| −3 | K133796 | Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD… | Marvao Medical Devices, Ltd. | 2014 | — |
| −2 | K140492 | Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use | Marvao Medical Devices, Ltd. | 2014 | — |
| −1 | K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32… | Marvao Medical Devices, Ltd. | 2016 | — |
| 0 (this device) | K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm)… | Marvao Medical Devices, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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.
2 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? (2)
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 |
|---|---|---|---|
| * | K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Summary page 4…Number: Product Code/ MSD/Gastroenterology /Urology Classification Panel: 1.3 Predicate Device(s) Primary K161026 Marvao NexSite HD Hemodialysis Cathet… | 2016 |
| * | K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm)Summary page 4…erm use, Manufactured by Marvao Medical Devices, Ltd. Secondary K171571 Marvao NexSite HD Hemodialysis Cathet… | 2017 |
| † | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2020 | Class II | Z-1699-2021 | Labeling Change Control | The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. |
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.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 12 of the 33 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173805: NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173805
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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