510(k) · Cleared
ClearedOptiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-Generic (Combined with Cathetr
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 Mar 28, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 28, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK010567 Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit…C.R. Bard, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
- Descendant · 2 generations on · 10 of its ownK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 5 of its ownK190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term…C. R. Bard · 2020
- Descendant · 4 generations on · 2 of its ownK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003 · cites it directly12descendants
- K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc. · 2003 · 2 generations on10descendants
- K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc. · 2005 · 2 generations on8descendants
- K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard · 2020 · 3 generations on5descendants
- K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010567 | Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000… | C.R. Bard, Inc. | 2001 | — |
| +1 | 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 | — |
| +2 | K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters | C.R. Bard, Inc. | 2005 | 13 |
| +3 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis… | C. R. Bard | 2020 | — |
| +4 | K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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?
- Of its descendants, K030020 (C.R. Bard, Inc., 2003) has gone furthest, with 12 descendants of its own.
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) | — |
https://510kreport.com/device/K010567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010567: Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-Generic (Combined with Cathetr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010567
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026