510(k) · Cleared
ClearedMedcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 11, 1998 after a 234-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 7 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 234 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- This deviceK973561 Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM…Medical Components, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK033570 Medcomp T-3Medcomp · 2004
- Descendant · 2 generations on · 2 of its ownK123292 T3Medcomp · 2013
- Descendant · 3 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
- Descendant · 4 generations on · 0 of its ownK232945 Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023
- Descendant · 2 generations on · 0 of its ownK181175 12F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K143102 Multi-Lumen Acute Hemodialysis Catheter for High…cites it directly · 2015
Most influential descendants
Showing 5 of 6 · See all- K033570Medcomp T-3Medcomp · 2004 · cites it directly4descendants
- K123292T3Medcomp · 2013 · 2 generations on2descendants
- K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 3 generations on1descendant
- K232945Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023 · 4 generations on0descendants
- K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973561 | Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow… | Medical Components, Inc. | 1998 | — |
| +1 | K033570 | Medcomp T-3 | Medcomp | 2004 | — |
| +2 | K123292 | T3 | Medcomp | 2013 | — |
| +3 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
| +4 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023 | — |
| +2 | K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2018 | 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.
1 device in this family has a Class I recall. 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K033570 (Medcomp, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973561: Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973561
Report an extraction error
Are you the manufacturer?
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