510(k) · Cleared
Recalled · Class II · 2018Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 26, 1999 after a 336-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 1999
- Review
- 336 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK981125 Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6Medical Components, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK123292 T3Medcomp · 2013
- Descendant · 2 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
- Descendant · 2 generations on · 1 of its ownK130851 Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012 · cites it directly3descendants
- K123292T3Medcomp · 2013 · cites it directly2descendants
- K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 2 generations on1descendant
- K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981125 | Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6 | Medical Components, Inc. | 1999 | — |
| +1 | K113487 | Hemo-Cath 10F, Hemo-Cath 12.5F | Medical Components, Inc. | 2012 | — |
| +1 | K123292 | T3 | Medcomp | 2013 | — |
| +2 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
| +2 | K130851 | Cascade Hemodialysis/Apheresis Catheter | Health Line International Corporation | 2014 | — |
| +3 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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 12.3 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
4 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 |
|---|---|---|---|---|
| Feb 23, 2018 | Class II | Z-1121-2018 | Nonconforming Material/Component | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113487 (Medical Components, Inc., 2012) has gone furthest, with 3 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/K981125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981125
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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