510(k) · Cleared
ClearedIntersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
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 Mar 17, 2017 as substantially equivalent to K926226 (Medtronic Vascular, 1993) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 17, 2017
- Review
- 17 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926226 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK926226 Intersept Filtered Cardiotomy ReservoirMedtronic Vascular · 1993 · Recalled
- This deviceK170583 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926226 | Intersept Filtered Cardiotomy Reservoir | Medtronic Vascular | 1993 | 1 |
| 0 (this device) | K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K926226 | Intersept Filtered Cardiotomy ReservoirSummary page 5…recovered from the field by suction the addition of medications or other fluids Contraindications Use the device only as indicated. Predicate Devices K926226 Intersept Filtered Cardiotomy Reservoir with Medtronic/Carmeda BioActive Surface Premarket Notification submission K926226, for t… | 1993 |
| * | K151110 | Intersept Filtered Cardiotomy ReservoirSummary page 6…22, 1993. This submission was for the initial introduction of the Intersept Filtered Cardiotomy Reservoir with Carmeda BioActive Surface into the market. K151110 Intersept Filtered Cardiotomy Reservoir Premarket Notification submission K151110, for the Intersept Cardiotomy Reservoir with fi… | 2015 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K926226.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Intersept filtered cardiotomy reservoir with Cortiva bioactive surface is indicated for use in the cardiopulmonary bypass circuit during surgery for:
• an air/fluid separation chamber
• a temporary storage reservoir for priming solution and blood
• the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction
• the addition of medications or other fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170583: Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170583
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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