---
kind: "section"
citation: "21 C.F.R. § 868.5115"
title: "21"
number: "868.5115"
heading: "Device to relieve acute upper airway obstruction."
url: "https://uscodex.org/cfr/21/868.5115"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter, subject to [§ 868.9](/cfr/21/868.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

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