21 CFR § 868.5795 - Tracheal tube cleaning brush.

---
identifier: "/us/cfr/t21/s868.5795"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5795 - Tracheal tube cleaning brush."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5795"
section_name: "Tracheal tube cleaning brush."
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"
---


# 868.5795 Tracheal tube cleaning brush.

(a) *Identification.* A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025]