510(k) · Cleared
ClearedElite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 16, 2013 as substantially equivalent to K081820 (Avalon Laboratories, LLC, 2008) after a 66-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 16, 2013
- Review
- 66 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003288 (2001). No later device cites it as a predicate yet.
- 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 deviceK130639 Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter…Maquet Cardiopulmonary, AG · 2013
View 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) | K130639 | Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I… | Maquet Cardiopulmonary, AG | 2013 | — |
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 |
|---|---|---|---|
| * | K081820 | Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRSummary page 1…ication: Class 11 Product Code: DWF CFR Section: 21 CFR 870.4210 Ill. Predicate Device: Avalon Elite®Bi-Caval Dual Lumen Catheter - K081820 IV. Device Description The Elite-i (RA) Dual Lumen (short lengths), Elite-i (Bi) Dual Lumen (standard) and Elite… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K081820.
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. 2013, 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 ELITE-i 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/K130639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130639: Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I (Bix)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/K130639
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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