Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319086

FEI Number

1319086

Entity Name

ONY BIOTECH INC.

City/State/Country

Amherst, NY, US

Establishment Address

455 Commerce Dr, Amherst, NY 14228, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ONY Biotech Inc. (Owner Number: 10092626)

Owner / Operator Contact Address

455 Commerce Dr, Amherst, NY 14228, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AerVia

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2025-01-29

Official Correspondent

Sindhu Row

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ONY Biotech 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.

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319086. Last updated year: 2026. Please use registration number 1319086 when referencing this establishment in official correspondence.