510(k) · Cleared
ClearedRetrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and Auto Inflate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Apr 11, 2003 as substantially equivalent to K860149 (Dlp, Inc., 1986) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Apr 11, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860149 (1986). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK860149 Venous Perfusion Cannula W/Cuff Cat. NO. 94015Dlp, Inc. · 1986 · Recalled
- This deviceK030696 Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line…Medtronic Perfusion Systems · 2003
- Descendant · cites it directly · 0 of its ownK132995 DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure…Medtronic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK123762 DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate CuffMedtronic, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860149 | Venous Perfusion Cannula W/Cuff Cat. NO. 94015 | Dlp, Inc. | 1986 | 9 |
| 0 (this device) | K030696 | Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French… | Medtronic Perfusion Systems | 2003 | — |
| +1 | K132995 | DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring… | Medtronic, Inc. | 2013 | — |
| +1 | K123762 | DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff | Medtronic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K860149 | Venous Perfusion Cannula W/Cuff Cat. NO. 94015Summary page 1…: Cardiopulmonary bypass vascular catheter, cannula or tubing Classification: Class I1 Predicate Devices: K860149: Venous Perfusion Return Cannula with cuff (14 French, Manual Inflate)… | 1986 |
| * | K901074 | Code #94315 Retrograde Coronary Sinus Perf CannulaSummary page 1…th cuff (14 French, Manual Inflate) Model 94015 And K90 1074: Retrograde Coronary Sinus Perfusion Cannula (15 French, Auto Inflate)… | 1990 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Retrograde Coronary Sinus Perfusion cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrograde through the coronary sinus up to six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030696: Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and Auto Inflate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030696
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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