510(k) · Decided
DecidedNextstep Retrograde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on May 10, 2013 as substantially equivalent to K111900 (Teleflexmedical, Inc., 2011) and 1 other predicate after a 105-day review. Its family tree reaches back 4 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 10, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010399 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 3 generations backK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004 · Recalled
- 2 generations backK102238 Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled
- 1 generation backK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled (Class I)
- This deviceK130192 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 1 of 1 · See all- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −3 | K040260 | Integral Hemodialysis Catheter | Arrow Int'L. | 2004 | 15 |
| −2 | K102238 | Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | 1 |
| −1 | K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | Class I |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111900 | Nextstep Antegrade Chronic Hemodialysis CatheterSummary page 2…xpanded indications to add femoral indications and increased lengths is substantially equivalent to the Arrow NextStep Antegrade Chronic Hemodialysis Catheters (KI 111900) and the Arrow NextStep Retrograde Chronic Hemodialysis Catheter (KRII 11117) in terms of overall design, manufacturing pro… | 2011 |
| * | K111117 | Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter… | 2011 |
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 |
|---|---|---|---|
| K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis… Class I | 2014 | 0 |
Has anything in its family been recalled? (3 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.
- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- 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 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K141051 (Arrow International, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111900.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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® Retrograde Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Retrograde Catheter is inserted percutaneously and is preferentially placed into the internal jugular (Ii) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 con are intended for femoral vein insertion. The Arrow NextStep Retrograde catheter is intended for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130192 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130192: Nextstep Retrograde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130192
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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