Medtronic Perfusion Systems: FDA clearances and approvals
Medtronic Perfusion Systems has 29 FDA 510(k) clearances (first 2000, latest 2024), across 12 product codes in 3 review panels. Median 510(k) review time: 36 days. openFDA lists 141 product recalls by a recalling firm named Medtronic Perfusion Systems.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 139 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 30 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 124 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medtronic Perfusion Systems's cleared 510(k)s took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 12 | 12 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 | 2 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (26)
- General Hospital (2)
- Hematology (1)
Most recent Medtronic Perfusion Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | DTZ | 2024-07-10 | 124 |
| K181954 | autoLog IQ Autotransfusion System | CAC | 2018-08-22 | 30 |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | DTM | 2013-03-19 | 139 |
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | DTP | 2010-09-03 | 128 |
| K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD | DWF | 2009-08-27 | 149 |
| K080824 | BIO-CONSOLE 560 | DWA | 2008-05-07 | 44 |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | DWF | 2006-06-23 | 50 |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | DWF | 2005-11-22 | 69 |
| K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | DWF | 2005-09-22 | 23 |
| K051303 | BIO-CONSOLE, MODEL 560 | DWA | 2005-06-10 | 22 |
19 earlier clearances. See the full list in Caduvo.
Recalls
141 product recalls in 49 recall events; 56 initiated in the last five years. Most recent: 2026-06-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Perfusion Systems have?
Medtronic Perfusion Systems has 29 FDA 510(k) clearances (first 2000, latest 2024), across 12 product codes in 3 review panels.
How long does FDA take to clear Medtronic Perfusion Systems's 510(k)s?
The median time from FDA receipt to decision across Medtronic Perfusion Systems's cleared 510(k)s is 36 days.
What devices does Medtronic Perfusion Systems make?
Its most frequent FDA product codes are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 12); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 4); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 2).
Has Medtronic Perfusion Systems had device recalls?
openFDA lists 141 product recalls in 49 recall events by a recalling firm whose name matches Medtronic Perfusion Systems; the most recent began 2026-06-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 29 Medtronic Perfusion Systems clearances with predicates and recalls
- Run predicate analysis for product code DWF, Medtronic Perfusion Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.