510(k) · Decided
Decided14F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 27, 2002 as substantially equivalent to K003207 (Medical Components, Inc., 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 27, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981994 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 1 generation backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- This deviceK021759 14F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55Medcomp · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −1 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| 0 (this device) | K021759 | 14F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55 | Medcomp | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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.
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 4 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
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) | — |
What is it indicated for?
THE MEDCOMP ULTRA-FLOW HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT.
ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED.
CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021759: 14F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021759
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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