510(k) · Decided
DecidedSplit Cath RG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · MSD Catheter, Hemodialysis, Implanted
Cleared on Apr 28, 2014 as substantially equivalent to K121848 (Medical Components, Inc., 2012) and 1 other predicate after a 395-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Apr 28, 2014
- Review
- 395 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981994 (1998). 7 ancestors in all, the oldest K971925 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 3 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 2 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 1 generation backK022678 Medcomp SC4Medcomp · 2003
- This deviceK130889 Split Cath RGMedcomp · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −3 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −2 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −1 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| 0 (this device) | K130889 | Split Cath RG | Medcomp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K121848 | Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii…Summary page 4…e March 25, 2013 Spiit Cath® Rg Catheter, Hemodiatysis. Implanted Blood Access device and accessories 876.5540 Gastroenterology and Urology L. MSD Predicate Devices: K121848. Split Cath® III concurrence date Sepiember 21, 2012. Class 11 CFR §876.5540 K022678 Split Cath IV (Split Sweam), concurrence dat… | 2012 |
| * | K022678 | Medcomp SC4Summary page 4…e and accessories 876.5540 Gastroenterology and Urology L. MSD Predicate Devices: K121848. Split Cath® III concurrence date Sepiember 21, 2012. Class 11 CFR §876.5540 K022678 Split Cath IV (Split Sweam), concurrence date February 24, 2003 Class 111 CFR §876.5540 Device Description: The Split Cath® Rg… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K121848.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Cath® Rg is indicated for use in attaining Long-Term vascular access for Hemodialysis 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 femoral vein.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130889: Split Cath RG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130889
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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