Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5880](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5880) → PIN — Kidney Perfusion Kit

# PIN · Kidney Perfusion Kit

_Gastroenterology, Urology · 21 CFR 876.5880 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/PIN

## Overview

- **Product Code:** PIN
- **Device Name:** Kidney Perfusion Kit
- **Regulation:** [21 CFR 876.5880](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5880)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/PIN](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/PIN)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com