510(k) · Cleared
ClearedAffinity Fusion Recirculation Line Model RCL841
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Oct 19, 2012 as substantially equivalent to K113845 (Medtronic, Inc., 2012) after a 28-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Oct 19, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K800178 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 2 generations backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 1 generation backK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- This deviceK122913 Affinity Fusion Recirculation Line Model RCL841Medtronic, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −2 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| −1 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| 0 (this device) | K122913 | Affinity Fusion Recirculation Line Model RCL841 | Medtronic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K113845 | Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceSummary page 2…Affinity Fusion® Recirculation Line is substantially equivalent to the legally marketed predicate device, Tubing, Connectors and Accessories with Balance® Biosurface (K(113845). Affinity@ Recirculation Line… | 2012 |
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 32 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K113845.
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. 2012, 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 recirculation line is indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122913: Affinity Fusion Recirculation Line Model RCL841.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122913
Report an extraction error
Are you the manufacturer?
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