510(k) · Decided
DecidedGlidePath 10F Long-Term Dialysis Catheter
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 Jun 22, 2020 as substantially equivalent to K190527 (C. R. Bard, 2020) and 1 other predicate after a 104-day review. Its family tree reaches back 7 generations to 1998. 1 of the 15 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 22, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K981994 (1998). 12 ancestors in all, the oldest K972207 (1998). 2 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 6 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 5 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 4 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- 3 generations backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- 2 generations backK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
- 1 generation backK190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term…C. R. Bard · 2020
- This deviceK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK202150 GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
Class I recalls in this family
- K984022 Pediatric Two-Lumen Hemodialysis Catherization Kit2 generations back · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −6 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −5 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −4 | K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2003 | — |
| −3 | K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with… | C.R. Bard, Inc. | 2003 | — |
| −2 | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | 13 |
| −1 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis… | C. R. Bard | 2020 | — |
| 0 (this device) | K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +1 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +2 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 1 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…Summary page 4…lation Number: 21 CFR 876.5540 Classification Panel: Gastroenterology/Urology Predicate Device: Bard GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020) Pediatric Reference Device: Medcomp Pediatric Ash Split Cath™ XL 10F (K020936, cleared October 11, 2002… | 2020 |
| * | K020936 | 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash…Summary page 4…edicate Device: Bard GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020) Pediatric Reference Device: Medcomp Pediatric Ash Split Cath™ XL 10F (K020936, cleared October 11, 2002)… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | 2020 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K984022Pediatric Two-Lumen Hemodialysis Catherization KitArrow Intl., Inc. · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 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 1.1 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202150 (C.R. Bard, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K190527.
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™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200627: GlidePath 10F Long-Term Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200627
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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