510(k) Report

510(k) · Decided

Decided

Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer

K033294510(k) SpecialDecided Nov 26, 200343-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 Nov 26, 2003 as substantially equivalent to K030020 (C.R. Bard, Inc., 2003) after a 43-day review. Its family tree reaches back 4 generations to 1998. 10 later devices descend from it.

Decided
Nov 26, 2003
Review
43 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K981994 (1998). 6 ancestors in all, the oldest K972207 (1998). 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor2009: 1 descendant cleared2005: 1 descendant cleared2006: 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) K030020 · Hemosplit Long-Term Hemodialysis Catheter · C.R. Bard, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K030020 · Hemosplit Long-Term Hemodialysis Catheter · C.R. Bard, Inc. · 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. · 19980+5
  1. Root · 4 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
  2. 3 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
  3. 2 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
  4. 1 generation backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
  5. This deviceK033294 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
  10. Descendant · 2 generations on · 1 of its ownK053589 Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12009: 12020: 32021: 22025: 1
2005high 3 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K981994Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc.1998—
−3K012562Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc.2002—
−2K020465Medcomp Ash Split-Cath IIMedcomp2002—
−1K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.2003—
0 (this device)K033294Hemosplit 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—
+2K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200910
202030
202120
202510
FIG. 1 — Lineage of K033294, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030020Hemosplit Long-Term Hemodialysis Catheter
Summary page 1
…hed for the requirement for premarket approval for the device described in paragraph (b)( 1). Predicate Device: HemoSplit Long-Term Hemodialysis Catheter, K030020, clearance date 6/16/03 Summary of Change: The modification to the HenioSplit Long-Term Dialysis Catheter is an incr…
C.R. Bard, Inc.2003—

Also cleared against K030020: 3 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.20058
K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.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 6 ancestors has a recall.
  • Of its descendants, K051748 (C.R. Bard, Inc., 2005) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate K030020.

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 Hernosplit 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 K030020

3 other devices cite the same predicate.

  • K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc. · 200915 recalls
  • K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006
  • K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc. · 200513 recalls

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/K033294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033294

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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