510(k) · Decided
DecidedGlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar 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 · MSD Catheter, Hemodialysis, Implanted
Cleared on Mar 5, 2020 as substantially equivalent to K051748 (C.R. Bard, Inc., 2005) after a 367-day review. Its family tree reaches back 6 generations to 1998. 5 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 367 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981994 (1998). 8 ancestors in all, the oldest K972207 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 5 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 4 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 3 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- 2 generations backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- 1 generation backK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
- This deviceK190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term…C. R. Bard · 2020
- Descendant · cites it directly · 2 of its ownK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK202150 GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
- Descendant · cites it directly · 0 of its ownK203575 GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK211410 GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · cites it directly2descendants
- K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 2 generations on1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 3 generations on0descendants
- K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021 · cites it directly0descendants
- K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −5 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −4 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −3 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| −2 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| −1 | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | 13 |
| 0 (this device) | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis… | C. R. Bard | 2020 | — |
| +1 | K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +2 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +3 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
| +1 | K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2021 | — |
| +1 | K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Bard Peripheral Vascular, Inc. | 2021 | — |
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 |
|---|---|---|
| 2020 | 2 | 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 12.3 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersSummary page 4…alysis Catheter HemoGlide™ Star Series XK Long-Term Dialysis Catheter (K051748, cleared August 12, 2005) Product Code: MSD Bard Access Systems, Inc.… | 2005 |
| † | K090101 | Equistream Long-Term Hemodialysis Catheters | 2009 |
| † | K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24… | 2008 |
What descends from it? (5)
3 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)
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 22 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K200627 (C.R. Bard, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K051748.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 GlidePath™ 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, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion.
The HemoStar™ and HemoStar™ 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, 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/K190527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190527
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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