Skip to content

Respironics Inc., Sleep & Home Respiratory Group

United StatesFDA applicant, unverified

Devices
21

What Respironics Inc., Sleep & Home Respiratory Group makes

Respironics Inc., Sleep & Home Respiratory Group manufactures respiratory devices including CPAP systems, BiPAP ventilatory support systems, and various face masks such as the PERFORMAX TOTAL FACE MASK and COMFORTGEL NASAL MASK.

The company's products are listed in the FDA 510(k) registry and are classified as Class II medical devices. Respironics Inc. is based in the US.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices
Skip device list

  • Performax Se Total Face Mask Ref K072588

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Performax Total Face Mask Ref K072592

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Remstar Auto A-Flex Ref K091319 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bipap Synchrony 2 Ventilatory Support System Ref K071509

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Comfort Twin Nasal Mask Ref K091843

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gas Transfill Ref K091191

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Remstar Aflex Cpap System Ref K063830

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Respironics Performax Total Face Mask Ref K091271

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bipap Autosv Advanced Ref K090539 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bipap Synchrony With Avaps Ref K070328

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bipap Autosv Ref K090248 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Comfortgel Nasal Mask Ref K092835

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Comfortgel Full Face Mask Ref K073600

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Wallaby 4 Ref K070180

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Remstar M-Series Auto With Aflex Cpap System Ref K090243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Respironics Performax Se Total Face Mask Ref K092648

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Revolutionfull Face Mask Ref K082866 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Alice Pdx Ref K090484

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Galaxy Ref K083874

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Comfort Twin Nasal Mask Ref K091066

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trilogy 100 Ventilator Ref K083526 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-21 of 21

Frequently asked questions

How many devices does Respironics Inc., Sleep & Home Respiratory Group have in the registry?

The registry currently lists 21 devices for Respironics Inc., Sleep & Home Respiratory Group. Devices recorded under merged duplicate company entries are counted once.

Which registries list Respironics Inc., Sleep & Home Respiratory Group's devices?

Among its 21 most recently registered devices, Respironics Inc., Sleep & Home Respiratory Group has devices listed in FDA 510(k) (21 devices).

What risk classes do Respironics Inc., Sleep & Home Respiratory Group's devices fall under?

Among its 21 most recently registered devices, the classes recorded for Respironics Inc., Sleep & Home Respiratory Group's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Respironics Inc., Sleep & Home Respiratory Group in the registry?

The most recently registered devices listed for Respironics Inc., Sleep & Home Respiratory Group include PERFORMAX SE TOTAL FACE MASK, PERFORMAX TOTAL FACE MASK, REMSTAR AUTO A-FLEX and BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.