Data / Medical devices / United States / Respironics, Inc.

Respironics, Inc.: FDA-registered device maker in New Kensington, PA, United States, 8 510(k) clearances

Name: Respironics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Respironics, Inc. is registered with the FDA (registration 3007220521) in New Kensington, PA, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 10, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007220521
Address: 312 Alvin Drive, New Kensington, PA, United States, 15068
Owner or operator: Philips Medical Systems International BV (2518422)
Roles: Manufacturer
First device listed: January 14, 2010
Registered through: 2026
Brand names listed: AOM (RIMR), BiPAP AVAPS or S/T C-Series, BiPAP Q-Series, BiPAP Q-Series w/HT, BiPAP autoSV Advanced, Dorma CPAP, DreamMapper, DreamStation BiPAP AVAPS w/ & w/o Humidifier and more

Devices it lists

Device	Product code	Class	Role	Source
Generator, Oxygen, Portable	CAW	2	Manufacturer	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Non-Life-Supporting	MNS	2	Manufacturer	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 10, 2020	K200480	DreamStation 2 System, DreamStation 2 Advanced System	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 18, 2013	K131982	REMSTAR AUTO A-FLEX HT	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 9, 2012	K122769	REMSTAR SE	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
December 16, 2011	K113068	REMSTAR AUTO A-FLEX HT	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
November 4, 2011	K111885	SIMPLYGO PORTABLE OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
January 22, 2010	K092818	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 30, 2009	K090539	BIPAP AUTOSV ADVANCED	MNS	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov
August 3, 2009	K091319	REMSTAR AUTO A-FLEX	BZD	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group	accessdata.fda.gov

Compare with other makers

Updated July 10, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.