21 CFR § 868.5115 - Device to relieve acute upper airway obstruction.

---
identifier: "/us/cfr/t21/s868.5115"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5115 - Device to relieve acute upper airway obstruction."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5115"
section_name: "Device to relieve acute upper airway obstruction."
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"
---


# 868.5115 Device to relieve acute upper airway obstruction.

(a) *Identification.* The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.

(b) *Classification.* Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.

[65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000]