Servator B SALF Solution
FDA 510(k) clearance K180481 · decided 2018-06-29
Clearance details
- K-number
- K180481
- Device name
- Servator B SALF Solution
- Applicant
- S.A.L.F. Spa
- Decision
- Substantially Equivalent
- Date received
- 2018-02-23
- Decision date
- 2018-06-29
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- KDN
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cenate Sotto, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch S.A.L.F. Spa
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 |
|---|---|---|
| Perfadex Plus (K261644) | Xvivo Perfusion AB | 2026-07-23 |
| VI°Port™ Liver Preservation System (K260456) | Traferox Technologies, Inc. | 2026-06-01 |
| BAROguard Donor Lung Preservation System (K254305) | Paragonix Technologies, Inc. | 2026-01-30 |
| EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618) | Bridge TO Life | 2025-06-17 |
| X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870) | Traferox Technologies, Inc. | 2025-05-01 |
| DCX Disposable Cassette (DCX) (K243998) | Institut Geroges Lopez | 2025-04-25 |
| Belzer UW® Cold Storage Solution (BTLBUW-001) (K243384) | Bridge TO Life | 2025-03-31 |
| Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (K243840) | Bridge TO Life | 2025-03-26 |
| LungProtect (K240650) | Traferox Technologies, Inc. | 2024-11-26 |
| KIDNEYvault Portable Renal Perfusion System (K234060) | Paragonix Technologies | 2024-10-23 |
| Servator P Plus SALF Solution (K230193) | S.A.L.F. Spa | 2023-09-21 |
| BAROguard (K223874) | Paragonix Technologies | 2023-08-15 |
Recalls involving this device
No recalls on record reference this clearance.