21 CFR § 868.5630 - Nebulizer.

---
identifier: "/us/cfr/t21/s868.5630"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5630 - Nebulizer."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5630"
section_name: "Nebulizer."
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"
---


# 868.5630 Nebulizer.

(a) *Identification.* A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

(b) *Classification.* Class II (performance standards).