Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2515872

FEI Number

2515872

Entity Name

DeVilbiss Healthcare LLC.

City/State/Country

SOMERSET, PA, US

Establishment Address

100 Devilbiss Dr, SOMERSET, PA 15501, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Drive DeVilbiss Healthcare (Owner Number: 10032050)

Owner / Operator Contact Address

99 Seaview Blvd, Port Washington, NY 11050, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071397

PMA Number

N/A

All Registered Proprietary Names

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) Traveler NexStride Pulmo-Neb Pulmo-Aide DeVilbiss 4650 Series Pulmo-Mate Drive DeVilbiss iGo 2 Portable Oxygen Concentrator Suction Canister DeVilbiss 5650 Series Pulmo-Aide DeVilbiss 73XX Series Suction Unit 10-Liter Oxygen Concentrator 5-Liter Oxygen Concentrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-04-28
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2016-09-20
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2025-09-09
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2010-04-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-04-05
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2010-04-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2018-07-09
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2017-03-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-04-05
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2010-04-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2010-04-05

Official Correspondent

Susan Scott

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Drive DeVilbiss Healthcare

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
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

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3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2515872. Last updated year: 2026. Please use registration number 2515872 when referencing this establishment in official correspondence.