Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008770104

FEI Number

3008770104

Entity Name

SOMNETICS INTERNATIONAL, INC

City/State/Country

Fridley, MN, US

Establishment Address

103 Osborne Road NE, Fridley, MN 55432, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Somnetics International, Inc (Owner Number: 10036212)

Owner / Operator Contact Address

103 Osborne Road NE, Fridley, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132127

PMA Number

N/A

All Registered Proprietary Names

Transcend AirFlex Transcend WhisperSoft Transcend 365 miniCPAP Auto Transcend 365 miniCPAP Transcend Auto Transcend 3 miniCPAP Auto Transcend EZEX Transcend 3 miniCPAP Transcend Micro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2022-07-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2018-12-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2018-12-27
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-11-06

Official Correspondent

Adrienne Schroll

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Somnetics International, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
3039065871	REEL FREE CORPORATION	Rockford, MI, US
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3013055504	BONREE MEDICAL CO., LTD	Zhongshan Guangdong, CN
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3009747810	NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD	Cixi Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008770104. Last updated year: 2026. Please use registration number 3008770104 when referencing this establishment in official correspondence.