510(k) · Cleared
Recalled · Class II · 2019Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 12, 2005 as substantially equivalent to K030020 (C.R. Bard, Inc., 2003) and 1 other predicate after a 44-day review. Its family tree reaches back 5 generations to 1998. 8 later devices descend from it. It has been recalled 13 times.
- Decided
- Aug 12, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981994 (1998). 7 ancestors in all, the oldest K972207 (1998). 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 4 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 3 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 2 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- 1 generation backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- This deviceK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term…C. R. Bard · 2020
- Descendant · 2 generations on · 2 of its ownK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK202150 GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK053589 Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006
- Descendant · 4 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard · 2020 · cites it directly5descendants
- K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 2 generations on2descendants
- K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 3 generations on1descendant
- K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006 · cites it directly1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −4 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −3 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −2 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| −1 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| 0 (this device) | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | — |
| +1 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis… | C. R. Bard | 2020 | — |
| +2 | K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +3 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +1 | K053589 | Long-Term Hemodialysis Catheters with Biobloc Coating | Bard Access Systems, Inc. | 2006 | — |
| +4 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
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 K241581 Hemodialysis Catheterscore 12.4 · 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 |
|---|---|---|---|
| * | K030020 | Hemosplit Long-Term Hemodialysis CatheterSummary page 1…Gastroenterology and Renal I-. -~ tditevOevicbEhIfit <410r~- dH~~tt HemoSplit Long-Term Heniodialysis Catheter K030020 6/16/2003 HemoSplit XK Long-Terin Heniodialywsi Catheter K033294 11/26/2003… | 2003 |
| * | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…Summary page 1…10r~- dH~~tt HemoSplit Long-Term Heniodialysis Catheter K030020 6/16/2003 HemoSplit XK Long-Terin Heniodialywsi Catheter K033294 11/26/2003 0o0038 ===… | 2003 |
| † | K010567 | Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless… | 2001 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2019 | Class II | Z-2388-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2390-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2386-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2387-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2385-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2392-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2393-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2384-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2395-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2391-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2394-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2383-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
| May 31, 2019 | Class II | Z-2389-2019 | Nonconforming Material/Component | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K190527 (C. R. Bard, 2020) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K030020.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 HemoGlide® Star series and HemoGlide® Star series XK long-term hemodialysis catheters are 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.
https://510kreport.com/device/K051748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051748
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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