AIRWAY INNOVATIONS, INC.

FDA Device Registration & Listing · Buffalo Grove, IL, US · Registration 3042617724

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042617724
FEI Number
3042617724
Entity Name
AIRWAY INNOVATIONS, INC.
City/State/Country
Buffalo Grove, IL, US
Establishment Address
1360 Busch Pkwy, Buffalo Grove, IL 60089, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Airway Innovations, Inc. (Owner Number: 10094592)
Owner / Operator Contact Address
1360 Busch Pkwy, Buffalo Grove, IL 60089, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AERIS Airway

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2025-12-09

Official Correspondent

Paul Fehrenbacher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Airway Innovations, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042617724. Last updated year: 2026. Please use registration number 3042617724 when referencing this establishment in official correspondence.
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