510(k) · Decided
DecidedNexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
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 Aug 9, 2016 as substantially equivalent to K121933 (Marvao Medical Devices, Ltd., 2013) and 3 other predicates after a 119-day review. Its family tree reaches back 12 generations to 2000. 2 of the 33 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 9, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K001901 (2000). 31 ancestors in all, the oldest K830256 (1983). 1 later device descends from it, 1 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK121933 Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd. · 2013
- 2 generations backK133796 Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite…Marvao Medical Devices, Ltd. · 2014
- 1 generation backK140492 Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014
- This deviceK161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm…Marvao Medical Devices, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK173805 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use…Marvao Medical Devices, Ltd. · 2018 · Recalled
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 7 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 6 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 5 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 4 generations backK110627 Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd. · 2011
- 3 generations backK121933 Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd. · 2013
- 2 generations backK133796 Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite…Marvao Medical Devices, Ltd. · 2014
- 1 generation backK140492 Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014
- This deviceK161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm…Marvao Medical Devices, Ltd. · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −7 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −6 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −5 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −4 | K110627 | Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter | Marvao Medical Devices, Ltd. | 2011 | — |
| −3 | K121933 | Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD… | Marvao Medical Devices, Ltd. | 2013 | — |
| −2 | K133796 | Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD… | Marvao Medical Devices, Ltd. | 2014 | — |
| −1 | K140492 | Nexsite HD (55CM), Hemodialysis Catheter for Long Term Use | Marvao Medical Devices, Ltd. | 2014 | — |
| 0 (this device) | K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32… | Marvao Medical Devices, Ltd. | 2016 | — |
| +1 | K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm)… | Marvao Medical Devices, Ltd. | 2018 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K121933 | Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Summary page 4…is, implanted Classification Number: 876.5540 Product Code/ Classification Panel: MSD/Gastroenterology /Urology III.PREDICATE DEVICE(S): K121933 / K133796 /K140492 Marvao NexSite HD Hemodialysis Catheter for long t… | 2013 |
| * | K133796 | Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Summary page 4…ted Classification Number: 876.5540 Product Code/ Classification Panel: MSD/Gastroenterology /Urology III.PREDICATE DEVICE(S): K121933 / K133796 /K140492 Marvao NexSite HD Hemodialysis Catheter for long term use, M… | 2014 |
| * | K140492 | Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseSummary page 4…sification Number: 876.5540 Product Code/ Classification Panel: MSD/Gastroenterology /Urology III.PREDICATE DEVICE(S): K121933 / K133796 /K140492 Marvao NexSite HD Hemodialysis Catheter for long term use, Manufactur… | 2014 |
| * | K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD…Summary page 4…ialysis Catheter for long term use, Manufactured by Marvao Medical Devices, Ltd. K143567 Marvao NexSite HD Hemodialysis Split Tip Catheter… | 2015 |
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 |
|---|---|---|---|
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD… | 2018 | 0 |
Has anything in its family been recalled? (2 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.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 6 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 · 7 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 12 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K173805 (Marvao Medical Devices, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121933.
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 NexSite HD Hemodialysis Step Tip Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161026: NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161026
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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