510(k) · Cleared
Recalled · Class II · 2016Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Oct 28, 2013 as substantially equivalent to K122914 (Medtronic, Inc., 2013) after a 35-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 28, 2013
- Review
- 35 days
- Class
- Class II
- Product code
- DTN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122914 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK122914 Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface…Medtronic, Inc. · 2013
- This deviceK132972 Affinity Fusion Cardiotomy/Venous Reservoir with Balance BiosurfaceMedtronic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK172626 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion…Medtronic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…Medtronic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122914 | Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface Model… | Medtronic, Inc. | 2013 | — |
| 0 (this device) | K132972 | Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface | Medtronic, Inc. | 2013 | — |
| +1 | K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator… | Medtronic, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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 |
|---|---|---|---|
| * | K122914 | Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface Model BB841…Summary page 1…1 870.4400 Product Code: DTN Name of Predicate Device: Affinity Fusion® Cardiotorny/enous Reservoir with Balance® Biosurface (K 122914) Reference Device: Affinity®0 NT Card iotomy/Venous Reservoir with Filter Model 540 (K936003)… | 2013 |
| † | K936003 | Affinity CVR | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2016 | Class II | Z-0826-2017 | Process control | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion… |
| Oct 31, 2014 | Class II | Z-0531-2015 | Process control | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K172626 (Medtronic, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, 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 · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132972: Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132972
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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