Sherpa Pak Kidney Transport System
FDA 510(k) K143054 · Paragonix Technologies, Inc.
510(k) numberK143054
Submission
- Device name
- Sherpa Pak Kidney Transport System
- Applicant
- Paragonix Technologies, Inc.
Braintree, MA, US - Received
- October 23, 2014
- Decision date
- November 25, 2014
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDN – System, Perfusion, Kidney
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261644 | Perfadex PlusKDN · Traditional | Xvivo Perfusion AB | 07/23/2026SE |
| K260456 | VI°Port Liver Preservation SystemKDN · Traditional | Traferox Technologies, Inc. | 06/01/2026SE |
| K254305 | BAROguard Donor Lung Preservation SystemKDN · Special | Paragonix Technologies, Inc. | 01/30/2026SE |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN · Traditional | Bridge TO Life | 06/17/2025SE |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional | Traferox Technologies, Inc. | 05/01/2025SE |
| K243998 | DCX Disposable Cassette (DCX)KDN · Traditional | Institut Geroges Lopez | 04/25/2025SE |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001)KDN · Traditional | Bridge TO Life | 03/31/2025SE |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN · Traditional | Bridge TO Life | 03/26/2025SE |
| K240650 | LungProtectKDN · Traditional | Traferox Technologies, Inc. | 11/26/2024SE |
| K234060 | KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional | Paragonix Technologies | 10/23/2024SE |
More from Paragonix Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K254305 | BAROguard Donor Lung Preservation SystemKDN · Special | 01/30/2026SE |
| K234060 | KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional | 10/23/2024SE |
| K223874 | BAROguardKDN · Traditional | 08/15/2023SE |
| K201048 | SherpaPak Pediatric Liver Transport SystemKDN · Traditional | 07/02/2020SE |
| K191440 | Paragonix SherpaPak Pancreas Transport SystemKDN · Traditional | 12/20/2019SE |
| K182735 | Paragonix SherpaPak Cardiac Transport SystemMSB · Special | 10/19/2018SE |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMSB · Traditional | 03/30/2018SE |
| K143074 | Sherpa Pak Cardiac Transport SystemMSB · Special | 11/25/2014SESK |
| K133694 | Sherpa Pak TransporterKDN · Traditional | 05/23/2014SE |
| K133432 | Sherpa Pak Cardiac Transport SystemMSB · Traditional | 02/21/2014SE |
Questions and answers
When was Sherpa Pak Kidney Transport System cleared by the FDA?
Sherpa Pak Kidney Transport System (K143054) received a 510(k) decision of Unknown on November 25, 2014, 33 days after the submission was received.
What is the product code of K143054?
The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.