Sherpa Pak Kidney Transport System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143054 FDA 510(k)
- FDA Product Code
- KDN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The Sherpa Pak Kidney Transport System is a perfusion system designed for the preservation and transport of donor kidneys. It provides a controlled environment to maintain organ viability during cold ischemic storage, ensuring safe transit from donor to recipient for transplantation.
The system consists of an outer shipper with non-ice temperature-controlled elements, an inner hard shell container for organ immersion in cold storage fluid, and an outer hard shell container with a temperature display and timer. Supplied as a sterile, single-use device, it is regulated under FDA 510(k) clearance (K143054) and falls under Class II medical device classification (876.5880).
Frequently asked questions
How is the Sherpa Pak Kidney Transport System designed to maintain kidney viability during transport?
The Sherpa Pak Kidney Transport System is engineered to provide a controlled, cold environment for donor kidneys during transport. It includes an outer shipper with non-ice temperature-controlled elements and an inner hard shell container where the kidney is immersed in cold storage fluid. This setup helps preserve organ viability by minimizing temperature fluctuations and maintaining optimal conditions for safe transit from donor to recipient.
Is the Sherpa Pak Kidney Transport System intended for reuse, or is it meant to be used only once?
The Sherpa Pak Kidney Transport System is explicitly designed as a sterile, single-use device. This ensures safety and hygiene for each organ transport, preventing cross-contamination between uses.
What regulatory pathway does the Sherpa Pak Kidney Transport System follow, and how does this affect its use?
The Sherpa Pak Kidney Transport System is cleared under the FDA 510(k) pathway (with clearance number K143054) and classified as a Class II medical device under product code KDN. This means it has undergone FDA review to ensure safety and effectiveness for its intended use in preserving and transporting donor kidneys, and it must comply with all applicable FDA regulations for distribution and use.
What components does the Sherpa Pak Kidney Transport System include, and how are they structured?
The system consists of three key components: an outer shipper with temperature-controlled elements, an inner hard shell container for immersing the kidney in cold storage fluid, and an outer hard shell container that includes a temperature display and timer. These layers work together to create a stable, monitored environment for organ preservation during transport.
Are there different sizes or models of the Sherpa Pak Kidney Transport System, or is it a one-size-fits-all solution?
The provided data does not specify multiple sizes or models for the Sherpa Pak Kidney Transport System, implying it is designed as a standardized, single-configuration device for kidney transport. However, the system’s design—including its inner and outer containers—appears tailored to accommodate the typical dimensions of a donor kidney while ensuring proper immersion in cold storage fluid.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 004_Attachment_3_Revised_510_k__Summary_K145054, SHERPA PAK TRANSPORTER (K133694) — FDA 510 (k) | Innolitics, Instructions for Use | Paragonix - Paragonix Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143054 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (1)
- FDA 510(k) K143054 24 fields · synced Sep 18, 2026