510(k) Report

510(k) · Cleared

Cleared

Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45 Series

K011916510(k) TraditionalCleared Oct 31, 2001133-day reviewClass II21 CFR 876.5540

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

Horizon Medical Products, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Oct 31, 2001 as substantially equivalent to K925819 (Akcess Medical Products, Inc., 1994) and 3 other predicates after a 133-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
Oct 31, 2001
Review
133 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K925819 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 2 other ancestors2002: 1 descendant clearedK925819 · AKCESS0CATH Kit · Akcess Medical Products, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K925819 · AKCESS0CATH Kit · Akcess Medical Products, Inc. · 19940
  1. Root · 1 generation backK925819 AKCESS0CATH KitAkcess Medical Products, Inc. · 1994
  2. This deviceK011916 Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series…Horizon Medical Products, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK022905 Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925819AKCESS0CATH KitAkcess Medical Products, Inc.1994—
0 (this device)K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40…Horizon Medical Products, Inc.2001—
+1K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K011916, 1994–2002Source: 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.

Planning a device in MSD? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K925819AKCESS0CATH Kit
Summary page 1
…uper C™ Hemodialysis/Apheresis Chronic Catheter Predicate 5§10(k)s: Akcess Cath Permanent Silicone Catheter - Horizon Medical Products, Inc. Chronic Dual Lumen Catheter (K925819); Vascath Opti-Flow (K981994 & K010567) and Ash Split Cath (K972207) June 18, 2001 Proprietary to Horizon Medica…
Akcess Medical Products, Inc.1994—
*K981994Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter
Summary page 1
…s Chronic Catheter Predicate 5§10(k)s: Akcess Cath Permanent Silicone Catheter - Horizon Medical Products, Inc. Chronic Dual Lumen Catheter (K925819); Vascath Opti-Flow (K981994 & K010567) and Ash Split Cath (K972207) June 18, 2001 Proprietary to Horizon Medical Products, Inc. Device Desc…
C.R. Bard, Inc.1998—
*K010567Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless…
Summary page 1
…Catheter Predicate 5§10(k)s: Akcess Cath Permanent Silicone Catheter - Horizon Medical Products, Inc. Chronic Dual Lumen Catheter (K925819); Vascath Opti-Flow (K981994 & K010567) and Ash Split Cath (K972207) June 18, 2001 Proprietary to Horizon Medical Products, Inc. Device Description: T…
C.R. Bard, Inc.2001—
*K972207Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM
Summary page 1
…Akcess Cath Permanent Silicone Catheter - Horizon Medical Products, Inc. Chronic Dual Lumen Catheter (K925819); Vascath Opti-Flow (K981994 & K010567) and Ash Split Cath (K972207) June 18, 2001 Proprietary to Horizon Medical Products, Inc. Device Description: The Super C™ Hemodialysis/Aphe…
Medcomp1998—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc.20020

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K022905 (Horizon Medical Products, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MSD devices

MSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Super C™ Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Horizon Medical Products, Inc.

16 FDA decisions under this applicant name. See the company

  • K033473Modification to Vortex MP Vascular Access PortHorizon Medical Products, Inc. · 20032 recalls
  • K032754Vortex MPHorizon Medical Products, Inc. · 20031 recall
  • K032557Triumph VTX with Lifevalve CatheterHorizon Medical Products, Inc. · 20031 recall
  • K031718Lifevalve Central Venous CathterHorizon Medical Products, Inc. · 2003
  • K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002

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/K011916 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011916: Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011916

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026