Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024841

FEI Number

2024841

Entity Name

PASSY-MUIR, INC.

City/State/Country

IRVINE, CA, US

Establishment Address

17992 Mitchell S Ste 200, IRVINE, CA 92614, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PASSY-MUIR, INC. (Owner Number: 2024841)

Owner / Operator Contact Address

17992 MITCHELL SOUTH, SUITE 200, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K903699

PMA Number

N/A

All Registered Proprietary Names

Passy Muir Low-Profile DB15 Adapter PM-DB15 Passy Muir DigiSil Digital (Finger) Occlusion Adapter PM-OCLN Passy-Muir Tracheostomy & Ventilator Swallowing and Speaking Valve PMV 007 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) Passy-Muir Low-Profile Tracheostomy Swallowing and Speaking Valve PMV 2020 PMV 005 Passy-Muir Tracheostomy & Ventilator and Speaking Valve PMV 2001 PMV 2000 Passy-Muir Low-Profile Tracheostomy & Ventilator Swallowing and Speaking Valve Passy Muir Heat Moisture Exchanger Passy-Muir Oxygen Adapter PMA 2000 PMV 007 Passy-Muir Tracheostomy & Ventilator Swallowing and Speaking Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-12-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2001-09-26
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-11-14
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2001-09-26
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2016-05-23
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	1993-01-18
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2001-09-26
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2025-01-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2001-09-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2001-09-26

Official Correspondent

Cameron Jolly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PASSY-MUIR, 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
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

Similar Registrations

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1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
8010939	VBM MEDIZINTECHNIK GMBH	SULZ AM NECKAR Baden-Wurttemberg, DE
3007962724	Nihon Kohden Tomioka Corporation	Gunma Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024841. Last updated year: 2026. Please use registration number 2024841 when referencing this establishment in official correspondence.