Data / Medical devices / Costa Rica / Respironics, Inc.
Respironics, Inc.: FDA-registered device maker in Coyol Alajuela, Costa Rica, 6 510(k) clearances
Respironics, Inc. is registered with the FDA (registration 3027553886) in Coyol Alajuela, Costa Rica. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated September 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027553886
- Address
- Coyol Free Zone and Business Park, Building B37, Coyol Alajuela, Costa Rica, 20101
- Owner or operator
- Philips Medical Systems International BV (2518422)
- Roles
- Manufacturer
- First device listed
- August 2, 2010
- Registered through
- 2026
- Brand names listed
- Altis Full Face Mask, Comfort Gel Blue Nasal Mask, DreamWear Full Mask, DreamWear Nasal Mask, DreamWisp Nasal Mask, Dreamwear Silicone Pillows Mask, S/M/L/MW Dreamwear Full Med Frm w/HGR, Shimmer Full Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| September 25, 2026 | K261262 | Altis Full Face Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| August 24, 2021 | K210844 | DreamWear Silicone Pillows Mask | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 10, 2015 | K140980 | TI NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| January 9, 2015 | K142554 | Revolution Full Face Mask | 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 12, 2010 | K092835 | COMFORTGEL NASAL MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2026. 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.