21 CFR § 868.5620 - Breathing mouthpiece.

---
identifier: "/us/cfr/t21/s868.5620"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5620 - Breathing mouthpiece."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5620"
section_name: "Breathing mouthpiece."
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"
---


# 868.5620 Breathing mouthpiece.

(a) *Identification.* A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

(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 § 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]