---
kind: "section"
citation: "21 C.F.R. § 868.5095"
title: "21"
number: "868.5095"
heading: "Retrograde intubation device."
url: "https://uscodex.org/cfr/21/868.5095"
---

# §868.5095. Retrograde intubation device.

- (a) **Identification.** A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles ([§ 868.5090](/cfr/21/868.5090.md)), syringe ([§ 880.5860](/cfr/21/880.5860.md) of this chapter), and hemostats ([§ 878.4800](/cfr/21/878.4800.md) of this chapter).
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
    - (i) Wire guide tensile, flex, fracture, and corrosion testing;
    - (ii) Catheter tensile strength testing at likely points of failure;
    - (iii) Catheter kink radius testing;
    - (iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids;
    - (v) Dimensional validation;
    - (vi) Accuracy testing of markings; and
    - (vii) **Validation of the maximum airway pressure.**
  - (2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (3) The device must be demonstrated to be biocompatible.
  - (4) Labeling must include:
    - (i) Instructions for use; and
    - (ii) **Package labels that clearly identify the minimum compatible size of endotracheal tube.**

## Notes

### Amendments

[86 FR 73678, Dec. 28, 2021]

### 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

[86 FR 73678, Dec. 28, 2021]