510(k) · Cleared
ClearedR501 aortic root cannula without vent line, R502 aortic root cannula with vent line
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 Nov 17, 2020 as substantially equivalent to K861310 (Shiley, Inc., 1986) after a 253-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- Nov 17, 2020
- Review
- 253 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861310 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK861310 Stockert-Shiley Aortic Root CannulaeShiley, Inc. · 1986
- This deviceK200612 R501 aortic root cannula without vent line, R502 aortic root cannula…Sorin Group Italia S.R.L. · 2020
- Descendant · cites it directly · 0 of its ownK240193 R501 - R502 aortic root cannulae with and without vent line…Sorin Group Italia S.R.L. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240193R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26.…Sorin Group Italia S.R.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861310 | Stockert-Shiley Aortic Root Cannulae | Shiley, Inc. | 1986 | — |
| 0 (this device) | K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent… | Sorin Group Italia S.R.L. | 2020 | — |
| +1 | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20… | Sorin Group Italia S.R.L. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K861310 | Stockert-Shiley Aortic Root CannulaeSummary page 5…cleared predicate device. Both models have the same fundamental scientific technology and intended use: 510(k) Number: K861310 Proprietary Name: R501 Aortic Root Cannula without vent line R… | 1986 |
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 |
|---|---|---|---|
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26.… | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K240193 (Sorin Group Italia S.R.L., 2024) has gone furthest, with 0 descendants of its own.
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. 2020, this device’s year, is highlighted.
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 Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200612: R501 aortic root cannula without vent line, R502 aortic root cannula with vent line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200612
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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