21 CFR § 878.5080 - Air-handling apparatus accessory.

---
identifier: "/us/cfr/t21/s878.5080"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.5080 - Air-handling apparatus accessory."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.5080"
section_name: "Air-handling apparatus accessory."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY 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: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 878.5080 Air-handling apparatus accessory.

(a) *Identification.* An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.

(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 § 878.9.

[84 FR 14870, Apr. 12, 2019]