Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800) → NXA — Tracheotomy Care Kit

# NXA · Tracheotomy Care Kit

_Anesthesiology · 21 CFR 868.5800 · Class 2_

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

## Overview

- **Product Code:** NXA
- **Device Name:** Tracheotomy Care Kit
- **Regulation:** [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K844051](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NXA/K844051.md) | SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT | Washington-Greene County Branch Pennsylvania Assoc | Jan 18, 1985 | SESE |

## Top Applicants

- Washington-Greene County Branch Pennsylvania Assoc — 1 clearance

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

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