21 CFR § 868.5800 - Tracheostomy tube and tube cuff.

---
identifier: "/us/cfr/t21/s868.5800"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5800 - Tracheostomy tube and tube cuff."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5800"
section_name: "Tracheostomy tube and tube cuff."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.5800 Tracheostomy tube and tube cuff.

(a) *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.

(b) *Classification.* Class II.

[51 FR 40389, Nov. 6, 1986]