Respironics, Inc.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 173
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2024-2012 | Class I | Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides contin | April 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | December 30, 2024 |
| K231313 | Therapy Mask 3100 NC/SP | July 28, 2023 |
| K210844 | DreamWear Silicone Pillows Mask | August 24, 2021 |
| K210386 | Magneto Nasal Mask | July 12, 2021 |
| K202142 | Sleepware G3 | October 29, 2020 |
| K201439 | Ventilator, Non-continuous (Respirator) | September 25, 2020 |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | July 10, 2020 |
| K183226 | Care Orchestrator Essence | October 18, 2019 |
| K183625 | SomnaPatch | October 18, 2019 |
| K181166 | Trilogy Evo | July 18, 2019 |
| K181170 | Trilogy Evo Universal | July 18, 2019 |
| K181053 | Care Orchestrator | January 4, 2019 |
| K161411 | Care Cycle Connect Application | February 17, 2017 |
| K151120 | Simple T Pediatric Nasal Mask | April 15, 2016 |
| K152356 | Sapphire | January 8, 2016 |
| K150638 | AF541 SE Full Face Mask | September 18, 2015 |
| K150639 | AF541 EE Full Face Mask | September 18, 2015 |
| K142988 | Sleepware G3 | March 16, 2015 |
| K140980 | TI NASAL MASK | February 10, 2015 |
| K142554 | Revolution Full Face Mask | January 9, 2015 |