21 CFR § 880.5400 - Neonatal incubator.

---
identifier: "/us/cfr/t21/s880.5400"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.5400 - Neonatal incubator."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.5400"
section_name: "Neonatal incubator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE 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: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.5400 Neonatal incubator.

(a) *Identification.* A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

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