Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009128734

FEI Number

2129616

Entity Name

CAIRE INC.

City/State/Country

Ball Ground, GA, US

Establishment Address

2205 Airport Industrial Dr, Ball Ground, GA 30107, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CAIRE Inc. (Owner Number: 9008476)

Owner / Operator Contact Address

2200 Airport Industrial Dr, Ste 500, Ball Ground, GA 30107, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960309

PMA Number

N/A

All Registered Proprietary Names

FreeStyle Focus FreeStyle 5 Saros Oxygen System HOMESTYLE Aspen Helios 300 Portable Companion 1000 and 1000T Portable Liquid Oxygen, Spirit Companion 21, 31, and 41 Helios 36 & 46 CR50 Ox Reg and Oxiclip PC20 NewLife Intensity NewLife Intensity 10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2016-01-14
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2011-01-06
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-06-27
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	Class 2	868.5655	2009-12-01
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	Class 2	868.5655	2009-12-02
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	Class 2	868.5655	2008-12-01
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	Class 2	868.5655	2009-12-01
BYJ	Unit, Liquid-Oxygen, Portable	Anesthesiology	Class 2	868.5655	2009-12-01
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2009-12-01
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2016-01-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAIRE Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004972304	CAIRE INC.	Ball Ground, GA, US
3009550619	CAIRE Medical Technology (Chengdu) Co., Ltd.	Chengdu Sichuan, CN

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
K941819	Hogan & Hartson	LIQUID OXYGEN STORAGE SUBSYSTEM	1994-05-23

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.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
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 3009128734. Last updated year: 2026. Please use registration number 3009128734 when referencing this establishment in official correspondence.