Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
FDA 510(k) clearance K250610 · decided 2025-06-27
Clearance details
- K-number
- K250610
- Device name
- Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-28
- Decision date
- 2025-06-27
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sorin Group Italia S.R.L.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043) | Smart Reactors | 2026-02-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Dual Stage Venous Cannulae (K253671) | Sorin Group Italia S.R.L. | 2026-01-30 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| AngioVac Cannula (K253106) | AngioDynamics, Inc. | 2025-10-24 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
| MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258) | Medtronic, Inc. | 2025-06-20 |
| Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248) | Spectrum Medical S.R.L. | 2024-05-31 |
| R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (K240193) | Sorin Group Italia S.R.L. | 2024-02-22 |
| EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (K233895) | Edwards Lifesciences | 2024-02-05 |
Recalls involving this device
No recalls on record reference this clearance.