510(k) · Decided
Recalled · Class I · 2026Nextstep Antegrade Chronic Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 17, 2011 as substantially equivalent to K102238 (Teleflexmedical, Inc., 2011) and 1 other predicate after a 43-day review. Its family tree reaches back 3 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 17, 2011
- Review
- 43 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010399 (2001). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 2 generations backK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004 · Recalled
- 1 generation backK102238 Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled
- This deviceK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK130192 Nextstep RetrogradeArrow International, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK141051 Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −2 | K040260 | Integral Hemodialysis Catheter | Arrow Int'L. | 2004 | 15 |
| −1 | K102238 | Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | 1 |
| 0 (this device) | K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | — |
| +1 | K130192 | Nextstep Retrograde | Arrow International, Inc. | 2013 | — |
| +1 | K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic… | Arrow International, Inc. | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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.
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? (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 |
|---|---|---|---|
| * | K102238 | Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterSummary page 1…anel Class Ill Regulation 21 CFR Part 876.5440 Product Code(s) MSD Legally marketed K1 02238 NextStep® Antegrade Chronic Hemodialysis Catheter device(s) to which Kil1117 Change in Material for Arrow In… | 2011 |
| * | K111117 | Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter… | 2011 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2026 | Class I | Z-2159-2026 | Nonconforming Material/Component | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure… |
| Feb 4, 2013 | Class II | Z-1007-2015 | Component design/selection | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. |
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.
- K111117Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde…Teleflexmedical, Inc. · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 13 Class I recalls
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130192 (Arrow International, Inc., 2013) has gone furthest, with 1 descendant 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. 2011, 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 Arrow® NextStep®D Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep®D Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep®@ Antegrade catheter is intended for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111900: Nextstep Antegrade Chronic 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/K111900
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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