510(k) · Cleared
ClearedMedcomp T-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Sep 16, 2004 as substantially equivalent to K020089 (The Kendall Company, 2002) and 1 other predicate after a 309-day review. Its family tree reaches back 1 generation to 1998. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Sep 16, 2004
- Review
- 309 days
- Class
- Class II
- Product code
- NIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973561 (1998). 2 ancestors in all. 4 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.
- Root · 1 generation backK973561 Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM…Medical Components, Inc. · 1998
- This deviceK033570 Medcomp T-3Medcomp · 2004
- 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 ownK181175 12F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018
Class I recalls in this family
- K020089 Mahurkar Triple Lumen Catheter, 12 FRdirect predicate · 2002
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
- K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973561 | Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow… | Medical Components, Inc. | 1998 | — |
| 0 (this device) | K033570 | Medcomp T-3 | Medcomp | 2004 | — |
| +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 | K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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.
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 NIE device
- #1 K232945 Trio-CT® Triple Lumen Catheter w/ Curved…score 9.4 · 11 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K020089 | Mahurkar Triple Lumen Catheter, 12 FRSummary page 1…implanted Classification: NIE C,F.R. Section: 876.5540 C. Predicate Devices: K020089 Mahurkar® Triple Lumen Catheter… | 2002 |
| * | K973561 | Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip…Summary page 1…ices: K020089 Mahurkar® Triple Lumen Catheter K973561 Medoomp® Tr-Flow TM Triple Lumen Catheter D. Device Description: The Medc… | 1998 |
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? (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.
- K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
What does this lineage say?
How does its category compare?
All NIE devicesNIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIE
Too few NIE 510(k)s in any year since 2007 to give a median.
Recalls per year · NIE
6in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NIE
72in 2025
MAUDE reports naming product code NIE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 1 | — | 1 | 61 |
| 2020 | 0 | — | 0 | 51 |
| 2021 | 0 | — | 0 | 61 |
| 2022 | 0 | — | 1 (1) | 119 |
| 2023 | 2 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 125 |
| 2025 | 0 | — | 6 | 72 |
| 2026 | 0 | — | 3 (1) | — |
What is it indicated for?
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR USE IN ATTAINING SHORT-TERM VASCULAR ACCESS FOR HEMODIALYSIS, APHERESIS AND INFUSION.
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.
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR A DURATION LESS THAN (30) DAYS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033570: Medcomp T-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033570
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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