510(k) Report

510(k) · Cleared

Cleared

Hemosplit Long-Term Hemodialysis Catheter

K030020510(k) AbbreviatedCleared Jun 16, 2003164-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

C.R. Bard, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Jun 16, 2003 as substantially equivalent to K010567 (C.R. Bard, Inc., 2001) and 1 other predicate after a 164-day review. Its family tree reaches back 3 generations to 1998. 12 later devices descend from it.

Decided
Jun 16, 2003
Review
164 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K981994 (1998). 5 ancestors in all, the oldest K972207 (1998). 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor2006: 1 descendant cleared2003: 1 descendant cleared2009: 2 descendants cleared2005: 1 descendant cleared2020: 3 descendants cleared2007: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant clearedK981994 · Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter · C.R. Bard, Inc. · 1998×2: 2 generations cleared close together, K012562 (2002), K020465 (2002) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K020465 · 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. · 19980+5
  1. Root · 3 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
  2. 2 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
  3. 1 generation backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
  4. This deviceK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
  5. Descendant · cites it directly · 10 of its ownK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
  6. Descendant · cites it directly · 8 of its ownK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term…C. R. Bard · 2020
  8. Descendant · 3 generations on · 2 of its ownK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
  9. Descendant · 4 generations on · 1 of its ownK202150 GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12007: 12009: 22020: 32021: 22025: 1
2003high 3 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc. · 2003 · cites it directly10descendants
  • K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc. · 2005 · cites it directly8descendants
  • K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard · 2020 · 2 generations on5descendants
  • K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 3 generations on2descendants
  • K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K981994Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc.1998—
−2K012562Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc.2002—
−1K020465Medcomp Ash Split-Cath IIMedcomp2002—
0 (this device)K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.2003—
+1K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.2003—
+1K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.200513
+2K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis…C. R. Bard2020—
+3K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.2020—
+4K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200710
200920
202030
202120
202510
FIG. 1 — Lineage of K030020, 1998–2025Source: 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? (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
*K010567Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless…C.R. Bard, Inc.2001—
*K020465Medcomp Ash Split-Cath II
Summary page 1
…Opti-Flow (renamed HemoGlide) Long-Term Hemodialysis Catheter, KO 10567, clearance date 3/28/200 1 + Medcomp Ash Split-Cath I1 Hemodialysis Catheter, K020465, clearance date 05/22/2002 Summary of Change: The modification to the HemoGlide Long-Term Dialysis Catheter, called HemoSp…
Medcomp2002—

Also cleared against K010567: 1 other device →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.200310
K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.20058
K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061
K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc.20090

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K033294 (C.R. Bard, Inc., 2003) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K010567.

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 HemoSplit long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.

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

Indications for use as stated in the FDA summary.

Also cleared against K010567

1 other device cites the same predicate.

  • K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45 SeriesHorizon Medical Products, Inc. · 2001

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K030020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030020: Hemosplit Long-Term 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/K030020

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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