510(k) · Decided
Decided12F Tri-Flow Triple Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. (dba MedComp) · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Jul 5, 2018 as substantially equivalent to K033570 (Medcomp, 2004) after a 64-day review. Its family tree reaches back 2 generations to 1998. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 5, 2018
- Review
- 64 days
- Class
- Class II
- Product code
- NIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973561 (1998). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK973561 Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM…Medical Components, Inc. · 1998
- 1 generation backK033570 Medcomp T-3Medcomp · 2004
- This deviceK181175 12F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2018
Class I recalls in this family
- K020089 Mahurkar Triple Lumen Catheter, 12 FR2 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K033570 | Medcomp T-3Summary page 4…ories Product Code: NIE 21 CFR Regulation: 876.5540 Class: Z Review Panel: Gastroenterology/Urology C. Predicate Device Predicate Trade Name: MEDCOMP® T-3 510(k) Number: K033570 510(k) Holder: Medical Components Inc. Device: Catheter, Hemodialysis, Triple Lumen, Non- Implanted Regulation Description: Blood… | 2004 |
| † | K123292 | T3 | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K033570.
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. 2018, this device’s year, is highlighted.
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 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-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 subclavian vein or femoral vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
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/K181175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181175: 12F Tri-Flow Triple Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181175
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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