510(k) · Cleared
ClearedRetrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences Research Medical · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jul 2, 1999 as substantially equivalent to K880103 (Research Medical, Inc., 1988) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Jul 2, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880103 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK880103 Catheter, Cannula and Tubing, Vascular, Cardiopul.Research Medical, Inc. · 1988
- This deviceK991170 Retrograde Cardioplegia Cannula with Duraflo Treatment, Model…Edwards Lifesciences Research Medical · 1999
- Descendant · cites it directly · 0 of its ownK123187 Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde…Edwards Lifesciences, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K123187Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter…Edwards Lifesciences, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul. | Research Medical, Inc. | 1988 | — |
| 0 (this device) | K991170 | Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014 | Edwards Lifesciences Research Medical | 1999 | — |
| +1 | K123187 | Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia… | Edwards Lifesciences, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul.Summary page 1…ar catheter, cannuia, or tubing. D. Predicate Devices Predicate Device A: Retroplegia Cannula, RC-014 Manufacturer: Baxter Research Medical, Inc. (BRM!) 510(k) Number: K880103 Predicate Device B: Extracorporeal Circuit with Duraflo Il Heparin Treatment Manufacturer: Baxter Healthcare Corporation 510(k)… | 1988 |
| * | K932208 | Extracorporeal Circuit W/Duraflo II Heparin TreatmSummary page 1…. (BRM!) 510(k) Number: K880103 Predicate Device B: Extracorporeal Circuit with Duraflo Il Heparin Treatment Manufacturer: Baxter Healthcare Corporation 510(k) Number: K932208 E. Device Description The Baxter Research Madical Retrograde Cardioplegia Cannula with Duraflo Treatment is a dual lumen cannul… | 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 |
|---|---|---|---|
| K123187 | Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter… | 2013 | 0 |
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 Cardioplegia Cannula with Duraflo Treatment is indicated for use in the dalivery of blood or cardiopteglc solution intraaperatively.
Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
This device is for short-term use only (< 6 h).
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/K991170 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991170: Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991170
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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