510(k) · Cleared
ClearedAvalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avalon Laboratories, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Oct 6, 2008 as substantially equivalent to K003288 (Origen Biomedical, Inc., 2001) after a 101-day review. Its family tree reaches back 1 generation to 2001. 19 later devices descend from it.
- Decided
- Oct 6, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003288 (2001). 19 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
- This deviceK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
- Descendant · cites it directly · 9 of its ownK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK180453 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK171610 MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K142673Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014 · cites it directly9descendants
- K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014 · cites it directly7descendants
- K180453Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018 · 2 generations on6descendants
- K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · 2 generations on5descendants
- K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003288 | Origen Dual Lumen Catheter | Origen Biomedical, Inc. | 2001 | — |
| 0 (this device) | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR… | Avalon Laboratories, LLC | 2008 | — |
| +1 | K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014 | — |
| +1 | K140999 | Tandemheart Veno-Venous Cannula | Cardiacassist, Inc. | 2014 | — |
| +2 | K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018 | — |
| +2 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016 | 1 |
| +1 | K171610 | MC3 QuickFlow Dual Lumen Catheter | Mc3 Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 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? (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 |
|---|---|---|---|
| * | K003288 | Origen Dual Lumen CatheterSummary page 2…cteristics and Substantial Equivalence: The Avalon EliteTM Bi-Caval Dual Lumen Catheter is substantially equivalent to the Origen Dual Lumen Catheter (K003288). Device comparisons show both products have the same intended use, and similar size ranges, materials, bifurcations,… | 2001 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142673 | Bio-Medicus Adult Cannulae and Introducer | 2014 | 9 |
| K140999 | Tandemheart Veno-Venous Cannula | 2014 | 7 |
| K171610 | MC3 QuickFlow Dual Lumen Catheter | 2017 | 3 |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | 2023 | 0 |
| K130639 | Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I (Bix)Dual… | 2013 | 0 |
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?
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The Avalon EliteTM Bi-Caval Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081820 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081820
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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