aerFree Airway Management System (AMS) 30-5001Recalls & reported problems

Sommetrics, Inc. · aerFree AMS utilizes patented aer+TM technology to simply and safely support the patency of the upper airway during medical procedures requiring mild to moderate levels of sedation. It is FDA-cleared for airway management in adults undergoing medical procedures of less than 2 hours in duration, where the patient is intended to receive mild to moderate sedation with non-propofol containing medications. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851167007001), received between Oct 6, 2020 and Oct 6, 2020 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Blister1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 6, 2020Adverse Event Without Identified Device or Use Problem
AN AIRWAY POSITIONING DEVICE, AERFREE AIRWAY MANAGEMENT SYSTEM (AMS), WAS APPLIED TO THE PT'S NECK AND THEN CONNECTED TO SUCTION. AT END OF PROCEDURE, THE DEVICE WAS REMOVED, AND BLISTERS WERE NOTED AT THE SITE.
Patient problems: Blister
MAUDE report 10634730 ↗

Device details

UDI-DI	`00851167007001`
Brand	aerFree Airway Management System (AMS)
Model	30-5001
Company	Sommetrics, Inc.
Product code	PMB · External Airway
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Aug 22, 2025

Device type (GMDN): External negative-pressure airway patency collar

A non-sterile, noninvasive device intended to be used to assist upper airway patency of a spontaneously breathing patient by applying external suction to the neck to hold the airway open, typically as an alternative to an artificial airway, continuous positive airway pressure (CPAP) device or chin lift. It consists of a moulded concave collar intended to be worn around the neck to function like a suction cup, and may include connection tubing (for connection to a suction pump); the suction pump is not included. This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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