510(k) · Cleared
Recalled · Class II · 2016Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Aug 26, 1997 as substantially equivalent to K896778 (Research Medical, Inc., 1990) and 4 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1979. It has been recalled once.
- Decided
- Aug 26, 1997
- Review
- 54 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K790564 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK790564 Adapter-StraightDlp, Inc. · 1979 · Recalled
- This deviceK972503 Cardioplegia Adapters, Vessel Canulae, and Aortic Root CannulaeSorin Group Italia S.R.L. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790564 | Adapter-Straight | Dlp, Inc. | 1979 | 1 |
| 0 (this device) | K972503 | Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae | Sorin Group Italia S.R.L. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 3 | 0 |
| 1990 | 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? (5)
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 |
|---|---|---|---|
| * | K896778 | Rmi Vasoplegia Cannula with & Without Check ValveSummary page 1…r. NAME OF PREDICATE OR LEGALLY MARKETED DEVICE The claim of substantial equivalence is based upon the following devices: o Research Medical, Inc. Vasoplegia Cannula (K 896778) designed for the delivery of cardioplegia solution to the heart during cardipulmonary bypass surgery, e DLP, Inc. Aortic Root C… | 1990 |
| * | K790565 | Aortic Root CannulaSummary page 1…nc. Vasoplegia Cannula (K 896778) designed for the delivery of cardioplegia solution to the heart during cardipulmonary bypass surgery, e DLP, Inc. Aortic Root Cannula (K790565) with and without a vent line designed for the delivery of cardioplegia solution and venting the left heart during cardiopulmonar… | 1979 |
| * | K791498 | Adapter-Y Type/Coronary PerfusionSummary page 1…nt line designed for the delivery of cardioplegia solution and venting the left heart during cardiopulmonary bypass surgery, e DLP, Inc. "Y" Adapter-Coronary Perfusion (K791498) is designed for delivery of cardioplegia solution during cardiopulmonary bypass surgery. e DLP, Inc.Straight Adapter (K790564)… | 1979 |
| * | K790564 | Adapter-StraightSummary page 1…DLP, Inc. "Y" Adapter-Coronary Perfusion (K791498) is designed for delivery of cardioplegia solution during cardiopulmonary bypass surgery. e DLP, Inc.Straight Adapter (K790564) is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line… | 1979 |
| * | K790563 | Adapters-Y-TypeSummary page 1…er (K790564) is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. e DLP, Inc. "Y” Adapters (K790563) is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the heart. DESCRIPTION OF D… | 1979 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2016 | Class II | Z-2757-2016 | Process control | The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 5 ancestors have a recall of any class.
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.
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 vessel cannula will be supplied with a wing or without a wing with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery. The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of…
Read the full statement (191 words)
The vessel cannula will be supplied with a wing or without a wing with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery.
The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of the cardiopulmonary bypass surgery. The aortic root cannula with vent line is designed to deliver cardioplegia solution and vent the heart during cardiopulmonary bypass surgery.
The cardioplegia "Y" perfusion adapter is designed for use with the aortic root cannula and vessel cannula to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia "Y" recirculation adapter is designed for use for recirculating of cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia straight adapter is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. The cardioplegia "Y" venting adapter is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the left heart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972503: Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972503
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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