Sunrise: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Sunrise”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRS | Device For Sleep Apnea Testing Based On Mandibular Movement | 1 | 0 |
Review panels
- Anesthesiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210015 | De Novo | Device For Sleep Apnea Testing Based On Mandibular Movement | 2022-01-07 |
Recalls
openFDA lists no recalls under a recalling firm named Sunrise.
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.
Device clinical trials
An industry sponsor named Sunrise is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05386836: The Sunrise SpO2 and Pulse Rate Accuracy Validation Study (Completed, started 2022-05-24)
- NCT05057975: Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis (Completed, started 2021-10-28)
- NCT04932486: Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea (Completed, started 2021-05-26)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sunrise Medical, Inc. (33 510(k)s)
- Sunrise Technologies, Inc. (18 510(k)s)
- Sunrise Medical Hhg, Inc. (10 510(k)s)
- Sunrise Medical (Us), LLC (5 510(k)s)
- Sunrise Medical Quickie Designs, Inc. (4 510(k)s)
- Sunrise SA (2 510(k)s)
- Sunrise International Business (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sunrise?
FDA lists 0 510(k) clearances under the applicant name “Sunrise”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Sunrise?
The most frequent FDA product codes under this applicant name are QRS (Device For Sleep Apnea Testing Based On Mandibular Movement, 1).
Next steps
- See all 0 Sunrise clearances with predicates and recalls
- Run predicate analysis for product code QRS, Sunrise'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.