510(k) · Decided
Recalled · Class II · 2014Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii 40CM and 55CM
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 Sep 21, 2012 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK121848 Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii…Medical 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 · 3 generations on · 0 of its ownK232945 Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023
- Descendant · cites it directly · 0 of its ownK130889 Split Cath RGMedcomp · 2014
Most influential descendants
Showing 4 of 4 · See all- K123292T3Medcomp · 2013 · cites it directly2descendants
- K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 2 generations on1descendant
- K232945Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023 · 3 generations on0descendants
- K130889Split Cath RGMedcomp · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121848 | Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM… | Medical Components, Inc. | 2012 | — |
| +1 | K123292 | T3 | Medcomp | 2013 | — |
| +2 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
| +3 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023 | — |
| +1 | K130889 | Split Cath RG | Medcomp | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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 |
|---|---|---|---|---|
| Aug 4, 2014 | Class II | Z-2592-2014 | Labeling False and Misleading | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123292 (Medcomp, 2013) has gone furthest, with 2 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. 2012, 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 Medcomp@ Split Oath® Ill is indicated for use in attaining long term vascular access for Hernodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. The Medcornp® Split Oath® IIl isindicated for…
Read the full statement (143 words)
The Medcomp@ Split Oath® Ill is indicated for use in attaining long term vascular access for Hernodialysis and Apheresis in the adult patient.
It may be inserted percutaneously and is primarily placed in the internal jugular vein.
Alternate insertion sites include the subclavian vein and inferior vena cava as required.
Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion.
The Medcornp® Split Oath® IIl isindicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patent.
It may be inserted percutaneously and is primarily placed in the internal jugular vein.
Aldternate insertion sites include the subclavian vein and inferior vena cava as required.
Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion.
Translumbar insertion via inferior vena cave isindicated when all other access sites are identified as non-viable.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121848: Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii 40CM and 55CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121848
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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