Data / Medical devices / United States / Respironics, Inc.
Respironics, Inc.: FDA-registered device maker in Mount Pleasant, PA, United States, 36 510(k) clearances
Respironics, Inc. is registered with the FDA (registration 3002797442) in Mount Pleasant, PA, United States. It lists 15 device types. The FDA files 36 510(k) clearances under its listings, the newest dated July 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002797442
- Address
- 174 Tech Center Drive, Mount Pleasant, PA, United States, 15666
- Owner or operator
- Philips Medical Systems International BV (2518422)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 1, 1999
- Registered through
- 2026
- Brand names listed
- 12/24V Battery Cable w/terminals or adapter, A30 Heated Humidifier, A40 Heated Humidifier, Alice 6 Headbox LDE, Alice 6 PSG Base Station LDE, Alice NightOne, Alice PDX, Alice PSG or components and more
Devices it lists
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 12, 2021 | K210386 | Magneto Nasal Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181170 | Trilogy Evo Universal | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181166 | Trilogy Evo | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 10, 2015 | K140980 | TI NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 20, 2014 | K140268 | SIMPLE T YOUTH NASAL MASK | 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 |
| March 6, 2013 | K122847 | KANGAROO NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 9, 2012 | K122769 | REMSTAR SE | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 5, 2012 | K121631 | SIMPLE T NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 1, 2012 | K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 16, 2011 | K113068 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| August 9, 2011 | K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| June 1, 2011 | K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | BZE | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| May 12, 2010 | K093905 | TRILOGY 202 VENTILATOR | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 12, 2010 | K092835 | COMFORTGEL NASAL MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 29, 2010 | K093416 | TRILOGY 200 VENTILATOR | CBK | 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 |
| June 26, 2009 | K090484 | ALICE PDX | MNR | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| March 13, 2009 | K083526 | TRILOGY 100 VENTILATOR | CBK | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 26, 2009 | K083874 | GALAXY | MNR | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| February 16, 2007 | K062689 | SIDESTREAM PLUS | CAF | Substantially Equivalent | Respironics , Ltd. | accessdata.fda.gov |
| June 22, 2006 | K060404 | AG-PLUS, MODEL 91210 | CAF | Substantially Equivalent | Medel S.P.A. | accessdata.fda.gov |
| December 13, 2005 | K052573 | STARDUST II | MNR | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 13, 2004 | K042655 | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 | CAF | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| March 18, 2004 | K040595 | ALICE 5 | OLZ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 13, 2003 | K032809 | HOSPITAL SPACER | CAF | Substantially Equivalent | Respironics Healthscan, Inc. | accessdata.fda.gov |
| January 3, 2003 | K023135 | IMAGE3 SE DISPOSABLE FULL FACE MASK | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| March 29, 2001 | K010263 | REMSTAR PLUS CPAP SYSTEM | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 30, 1999 | K991725 | SIDESTREAM NEBULIZER | CAF | Substantially Equivalent | Inspired Medical Products , Ltd. | accessdata.fda.gov |
| July 13, 1998 | K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR | MNR | Substantially Equivalent | Pro-Tech Services, Inc. | accessdata.fda.gov |
| October 17, 1996 | K962822 | OPTICHAMBER | CAF | Substantially Equivalent | Healthscan Products, Inc. | accessdata.fda.gov |
| July 15, 1996 | K961077 | PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE | BWF | Substantially Equivalent | Healthscan Products, Inc. | accessdata.fda.gov |
| November 16, 1992 | K924123 | SIDESTREAM DISPOSABLE | CAF | Substantially Equivalent | Medic-Aid , Ltd. | accessdata.fda.gov |
| March 31, 1987 | K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | BWF | Substantially Equivalent | Health Products, Inc. | accessdata.fda.gov |
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Updated July 12, 2021. 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.