Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5650](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5650) → CAO — Airway, Esophageal (Obturator)

# CAO · Airway, Esophageal (Obturator)

_Anesthesiology · 21 CFR 868.5650 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO

## Overview

- **Product Code:** CAO
- **Device Name:** Airway, Esophageal (Obturator)
- **Regulation:** [21 CFR 868.5650](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5650)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K971348](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K971348.md) | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Green Field Medical Sourcing, Inc. | Feb 27, 1998 | SESE |
| [K894032](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K894032.md) | EVAC-TUBE | Sharn, Inc. | Aug 31, 1989 | SESE |
| [K875226](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K875226.md) | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Sheridan Catheter Corp. | Jan 19, 1988 | SESE |
| [K864200](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K864200.md) | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Cranco Co. | Mar 17, 1987 | SESE |
| [K863172](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K863172.md) | RESPIRONICS PTL REVIVEEASY | Respironics, Inc. | Nov 4, 1986 | SESE |
| [K761195](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO/K761195.md) | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | Dec 9, 1976 | SESE |

## Top Applicants

- Cranco Co. — 1 clearance
- Green Field Medical Sourcing, Inc. — 1 clearance
- Mckesson Corp. — 1 clearance
- Respironics, Inc. — 1 clearance
- Sharn, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAO)

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