510(k) · Cleared
Recalled · 2011Arrow (R) Nextstep TM 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 Feb 1, 2011 as substantially equivalent to K040260 (Arrow Int'L., 2004) after a 176-day review. Its family tree reaches back 2 generations to 2001. 2 of the 6 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2011
- Review
- 176 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010399 (2001). 3 later devices descend from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 1 generation backK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004 · Recalled
- This deviceK102238 Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK130192 Nextstep RetrogradeArrow International, Inc. · 2013
- Descendant · 2 generations on · 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 3 of 3 · See all- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · cites it directly2descendants
- K130192Nextstep RetrogradeArrow International, Inc. · 2013 · 2 generations on1descendant
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −1 | K040260 | Integral Hemodialysis Catheter | Arrow Int'L. | 2004 | 15 |
| 0 (this device) | K102238 | Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | — |
| +1 | K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | Class I |
| +2 | K130192 | Nextstep Retrograde | Arrow International, Inc. | 2013 | — |
| +2 | K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic… | Arrow International, Inc. | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 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.
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? (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 |
|---|---|---|---|
| * | K040260 | Integral Hemodialysis CatheterSummary page 1…21 CFR Part 876.5540, Catheter, Hemodialysis, name: Implanted Legally marketed Integral Chronic Hemodialysis Catheter (K040260) devices to which the device is substantially equivalent: Description of the The Arrow@ NextStepTM Antegrade Chroni… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter Class I | 2011 | 2 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2011 | Not classified | Z-2883-2011 | Device Design | Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters. |
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.
- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · 2 generations on · ◆ 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 6.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K111900 (Teleflexmedical, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K040260.
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® NextStepTm Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep TM Antegradle 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® NextSte pTm Antegrade catheter is intended for use in adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102238: Arrow (R) Nextstep TM 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/K102238
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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