510(k) · Cleared
ClearedMC3 QuickFlow Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mc3 Incorporated · PZS Dual Lumen Ecmo Cannula
Cleared on Nov 16, 2017 as substantially equivalent to K081820 (Avalon Laboratories, LLC, 2008) after a 168-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 16, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- PZS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003288 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- 1 generation backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- This deviceK171610 MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017
- Descendant · cites it directly · 2 of its ownK180151 MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK232480 ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK203409 MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| −1 | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| 0 (this device) | K171610 | MC3 QuickFlow Dual Lumen Catheter | Mc3 Incorporated | 2017 | — |
| +1 | K180151 | MC3 Jugular Dual Lumen Catheter | Mc3 Incorporated | 2018 | — |
| +2 | K232480 | ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. | 2023 | — |
| +2 | K203409 | MC3 Crescent Jugular Dual Lumen Catheter | Mc3, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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.
Planning a device in PZS? 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 PZS device
- #1 K232480 ProtekDuo Veno-Venous Cannula Setsscore 7.3 · 5 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 |
|---|---|---|---|
| * | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRSummary page 4…0 Product Code: PZS Predicate Device: 81 FR 7451, Feb. 12, 2016 Secondary Predicate Device: Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) Indications for Use: The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both ven… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180151 | MC3 Jugular Dual Lumen Catheter | 2018 | 2 |
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 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180151 (Mc3 Incorporated, 2018) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K081820.
How does its category compare?
All PZS devicesPZS Dual Lumen Ecmo Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PZS
Too few PZS 510(k)s in any year since 2007 to give a median.
Recalls per year · PZS
No recall names PZS since 2007.
Adverse event reports per year · PZS
34in 2025
MAUDE reports naming product code PZS, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 28 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3l/min) where other…
Read the full statement (176 words)
The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171610: MC3 QuickFlow Dual 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/K171610
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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