Circadiance, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Circadiance, LLC” (first 2009, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 42 |
| 2013 | 1 | 88 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 288 |
| 2017 | 1 | 149 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Circadiance, LLC took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Circadiance, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162905 | SleepWeaver 3D Nasal Mask | BZD | 2017-03-15 | 149 |
| K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | BZD | 2016-04-05 | 288 |
| K130481 | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK | BZD | 2013-05-24 | 88 |
| K120757 | SLEEPWEAVER ELAN NASAL CPAP MASK | BZD | 2012-04-24 | 42 |
| K092362 | SLEEPWEAVER NASAL CPAP MASK | BZD | 2009-11-02 | 90 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-05-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Circadiance, LLC?
FDA lists 5 510(k) clearances under the applicant name “Circadiance, LLC” (first 2009, latest 2017), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Circadiance, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circadiance, LLC is 90 days.
Which FDA product codes appear under Circadiance, LLC?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 5).
Next steps
- See all 5 Circadiance, LLC clearances with predicates and recalls
- Run predicate analysis for product code BZD, Circadiance, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.