Circadiance LLC
FDA Regulatory Profile
Circadiance LLC appears in FDA public data with 1 recall, 5 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2250-2017, Class II) was initiated on May 1, 2017. Its most recent 510(k) clearance was granted on March 15, 2017.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2250-2017 | Class II | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitorin | May 1, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162905 | SleepWeaver 3D Nasal Mask | March 15, 2017 |
| K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | April 5, 2016 |
| K130481 | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK | May 24, 2013 |
| K120757 | SLEEPWEAVER ELAN NASAL CPAP MASK | April 24, 2012 |
| K092362 | SLEEPWEAVER NASAL CPAP MASK | November 2, 2009 |