510(k) Report

510(k) · Decided

Recalled · Class I · 2026

Duramax Chronic Hemodialysis Catheter and Procedure Kit

K101843510(k) TraditionalDecided Oct 20, 2010111-day reviewClass II21 CFR 876.5540Recalls 30 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

AngioDynamics, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Oct 20, 2010 as substantially equivalent to K080400 (AngioDynamics, Inc., 2008) and 1 other predicate after a 111-day review. Its family tree reaches back 7 generations to 1998. 2 of the 18 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 30 times, including a Class I recall.

Decided
Oct 20, 2010
Review
111 days
Class
Class II
Product code
MSD
Recalls
30 (1 Class I)
Predicates
2

Its longest line of descent runs back 7 generations to K981994 (1998). 15 ancestors in all, the oldest K972207 (1998). 2 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2003: 1 other ancestor2001: 3 other ancestors1998: 2 other ancestors2011: 1 descendant cleared2014: 1 descendant cleared, 1 with a Class I recall1K981994 · Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter · C.R. Bard, Inc. · 1998×2: 2 generations cleared close together, K012562 (2002), K020465 (2002) K022678 · Medcomp SC4 · Medcomp · 2003K040318 · Medcomp Split-Cath II · Medcomp · 2005K070572 · Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM · Ash Access Technology, Inc. · 2007 · recalledK080400 · Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit · AngioDynamics, Inc. · 2008 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants, 1 with a Class I recall1 K080400 · Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit · AngioDynamics, Inc. · 2008 · recalledK070572 · Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM · Ash Access Technology, Inc. · 2007 · recalledK040318 · Medcomp Split-Cath II · Medcomp · 2005K022678 · Medcomp SC4 · Medcomp · 2003K020465 · Medcomp Ash Split-Cath II · Medcomp · 2002K012562 · Medcomp 14.5F Double Lumen Hemodialysis Catheter · Medical Components, Inc. · 2002K981994 · Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter · C.R. Bard, Inc. · 1998−50
  1. Root · 7 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
  2. 6 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
  3. 5 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
  4. 4 generations backK022678 Medcomp SC4Medcomp · 2003
  5. 3 generations backK040318 Medcomp Split-Cath IIMedcomp · 2005
  6. 2 generations backK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
  7. 1 generation backK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
  8. This deviceK101843 Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010
  9. Descendant · cites it directly · 0 of its ownK131260 Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · Recalled (Class I)
  10. Descendant · cites it directly · 0 of its ownK110936 Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2011 · Recalled

Class I recalls in this family

  • K131260 Nmi Dialysis Cathetercites it directly · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · cites it directly0descendants
  • K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K981994Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc.1998—
−6K012562Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc.2002—
−5K020465Medcomp Ash Split-Cath IIMedcomp2002—
−4K022678Medcomp SC4Medcomp2003—
−3K040318Medcomp Split-Cath IIMedcomp2005—
−2K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR…Ash Access Technology, Inc.20073
−1K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20085
0 (this device)K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.2010—
+1K131260Nmi Dialysis CatheterNavilyst Medical, Inc.2014Class I
+1K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20116

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
200130
200310
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201411
FIG. 1 — Lineage of K101843, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241581 Hemodialysis Catheterscore 12.3 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit
Summary page 1
…Manufacture~r 510(k) No.., AngloDynamics% DuraMax" Catheter Kits AngioDyna-mi-cs K080400, cleared _____ ____ ____ ____ ________ ____ ___ ____ _…
AngioDynamics, Inc.20085
*K040402Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit
Summary page 1
…____ ________ ____ ___ ____ ____ ____ ____ 5/13/08 AngioDynarnicsT EvenMore"' Chronic AngioDynamics"' K040402, cleared H-emodialysis Catheter 4/19/2004 Device Des…
AngioDynamics, Inc.2004—

Also cleared against K080400: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131260Nmi Dialysis Catheter Class INavilyst Medical, Inc.20140
K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20110

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 13, 2026Class IZ-1578-2026Process control16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for…
Mar 18, 2024Class IIZ-1771-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1772-2024Under Investigation by firmXXX
Mar 18, 2024Class IIZ-1766-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1767-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1768-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1769-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1773-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Mar 18, 2024Class IIZ-1770-2024Under Investigation by firmTri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Dec 30, 2011Not classifiedZ-0719-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0720-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0721-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0724-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0725-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0726-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0729-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0730-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0731-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0732-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0718-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0722-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0723-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0727-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0728-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Dec 30, 2011Not classifiedZ-0733-2012Nonconforming Material/ComponentThe securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Jan 24, 2011Not classifiedZ-0588-2012Nonconforming Material/ComponentAngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Jan 24, 2011Not classifiedZ-0589-2012Nonconforming Material/ComponentAngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Jan 24, 2011Not classifiedZ-0586-2012Nonconforming Material/ComponentAngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Jan 24, 2011Not classifiedZ-0590-2012Nonconforming Material/ComponentAngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
Jan 24, 2011Not classifiedZ-0587-2012Nonconforming Material/ComponentAngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.

The 5 latest of 30 recalls; the web page lists all.

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.

  • K131260Nmi Dialysis CatheterNavilyst Medical, 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 5 companies; a new generation was cleared every 1.9 years on median.
  • 5 of the 15 ancestors have a recall of any class.
  • Of its descendants, K131260 (Navilyst Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K080400.

How does its category compare?

All MSD devices

MSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MSD

1in 2025

2007: 72008: 32009: 62010: 42011: 72012: 22013: 52014: 82015: 12016: 22017: 22018: 22019: 12020: 42021: 42025: 1
2007high 8 (2014) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSD

153in 2021

2007: 92 days median2008: 89 days median2009: 81 days median2010: 116 days median2011: 70 days median2013: 105 days median2014: 246 days median2020: 106 days median2021: 153 days median
2007high 246 (2014) · low 70 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSD

1in 2013

2008: 472009: 492010: 112011: 242013: 12026 (partial year): 4, 4 Class I
2007high 49 (2009) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MSD

1,054in 2025

2007: 1182008: 1742009: 1732010: 3062011: 2682012: 3672013: 3632014: 5062015: 5502016: 5322017: 4842018: 4632019: 6452020: 4012021: 5232022: 6102023: 5422024: 8412025: 1,054
2007high 1,054 (2025) · low 118 (2007)2025

MAUDE reports naming product code MSD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077920118
200838947174
200968149173
2010411611306
201177024268
20122—0367
201351051363
201482460506
20151—0550
20162—0532
20172—0484
20182—0463
20191—0645
202041060401
202141530523
20220—0610
20230—0542
20240—0841
20251—01,054
20260—4 (4)—

What is it indicated for?

The AngioDynamics, Inc. Duralvax~i Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include the subclavian vein as required.

Catheters greater than 40cm are intended for femoral vein insertion.

This catheter is indicated for > 30 days long-term placement.

Indications for use as stated in the FDA summary.

Also cleared against K080400

1 other device cites the same predicate.

  • K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009

More from AngioDynamics, Inc.

87 FDA decisions under this applicant name. See the company

  • K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025
  • K253106AngioVac CannulaAngioDynamics, Inc. · 2025
  • K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090)…AngioDynamics, Inc. · 2024
  • K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc. · 2024
  • K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc. · 2023

Recent decisions in MSD

The MSD category page

  • K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025
  • K210461End CapMedical Components Inc (Medcomp) · 2021
  • K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021
  • K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021
  • K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. · 2021

https://510kreport.com/device/K101843 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101843

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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