Company ยท US
Circadiance, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2017. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 15, 2017 | K162905 | SleepWeaver 3D Nasal Mask Circadiance, LLC | BZD |
| Apr 5, 2016 | K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask Circadiance, LLC | BZD |
| May 24, 2013 | K130481 | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK Circadiance, LLC | BZD |
| Apr 24, 2012 | K120757 | SLEEPWEAVER ELAN NASAL CPAP MASK Circadiance, LLC | BZD |
| Nov 2, 2009 | K092362 | SLEEPWEAVER NASAL CPAP MASK Circadiance, LLC | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2017 | Circadiance LLC SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE.
Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. Terminated |
NPE | K061256 |