Product code DWF: 510(k) clearances and predicates
Product code DWF covers Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae. FDA lists 401 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
401 clearances on file under product code DWF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 so far | 6 |
Recent clearances
Newest DWF clearances in the FDA index, with applicant and decision date:
- K260195, Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae, applicant Medtronic, Inc., decided 2026-04-23. FDA record
- K250937, Venous Return Cannulae, applicant LivaNova USA, Inc., decided 2026-03-11. FDA record
- K260043, Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C), applicant Smart Reactors, decided 2026-02-23. FDA record
- K253203, Retrograde Coronary Sinus Perfusion Cannulae, applicant Medtronic, Inc., decided 2026-02-19. FDA record
- K253671, Dual Stage Venous Cannulae, applicant Sorin Group Italia S.R.L., decided 2026-01-30. FDA record
- K253998, Clearview Intracoronary Shunts, applicant Medtronic, Inc., decided 2026-01-20. FDA record
- K253106, AngioVac Cannula, applicant AngioDynamics, Inc., decided 2025-10-24. FDA record
- K250283, RAP Femoral Venous Cannulae, applicant LivaNova USA, Inc., decided 2025-07-10. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Venous Return Cannulae, Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C). Watch new DWF clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DWF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DWF clearances include Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae.
How many 510(k) clearances use product code DWF?
401 at the time this page was generated, from openFDA records.
How do I find a predicate device under DWF?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DWF clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.