510(k) · Cleared
ClearedAortic Arch Cannulae, Optiflow Aortic Arch 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 Jun 16, 2017 as substantially equivalent to K870825 (Shiley, Inc., 1987) after a 312-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jun 16, 2017
- Review
- 312 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870825 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK870825 New Model Styles for Aortic Arch CannulaShiley, Inc. · 1987
- This deviceK162215 Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L. · 2017
- Descendant · cites it directly · 0 of its ownK180979 PureFlex Arterial CannulaeSorin Group Italia S.R.L. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180979PureFlex Arterial CannulaeSorin Group Italia S.R.L. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870825 | New Model Styles for Aortic Arch Cannula | Shiley, Inc. | 1987 | — |
| 0 (this device) | K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. | 2017 | — |
| +1 | K180979 | PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K870825 | New Model Styles for Aortic Arch CannulaSummary page 4…tubing CLASSIFICATION CODE: DWF REGULATION NUMBER: 870.4210 PRIMARY PREDICATE DEVICE: Aortic Arch Cannulae K870825 REFERENCE DEVICE: Aortic Arch Cannulae K870826 DEVICE DESCRIPTION: The devices are intended to be us… | 1987 |
| † | K870826 | Additional Letter Designation for Aortic Arch Can. | 1987 |
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 |
|---|---|---|---|
| K180979 | PureFlex Arterial Cannulae | 2018 | 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, K180979 (Sorin Group Italia S.R.L., 2018) 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. 2017, 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?
Aortic Arch Cannulae:
The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.
Optiflow Aortic Arch Cannulae:
The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.
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/K162215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162215: Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162215
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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