---
kind: "section"
citation: "21 C.F.R. § 868.5454"
title: "21"
number: "868.5454"
heading: "High flow humidified oxygen delivery device."
url: "https://uscodex.org/cfr/21/868.5454"
---

# §868.5454. High flow humidified oxygen delivery device.

- (a) **Identification.** A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
    - (i) Alarm testing must be performed;
    - (ii) Continuous use thermal stability testing must be performed;
    - (iii) Humidity output testing must be performed; and
    - (iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2) blending accuracy.
  - (3) Performance data must validate cleaning instructions for any reusable components of the device.
  - (4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Labeling must include:
    - (i) A description of available FiO2 ranges for different flowrates and inlet gas pressures;
    - (ii) Instructions for applicable flowrates for all intended populations;
    - (iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
    - (iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
    - (v) **A description of all alarms and their functions.**

## Notes

### Amendments

[83 FR 54007, Oct. 26, 2018]

### 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

[83 FR 54007, Oct. 26, 2018]