Nightware, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Nightware, Inc.”, 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 |
|---|---|---|---|
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200033 | De Novo | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | 2020-11-06 |
Recalls
openFDA lists no recalls under a recalling firm named Nightware, Inc..
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 Nightware, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04040387: NightWare Randomized Trial 02 (Completed, started 2019-07-24)
- NCT03934658: Remote Study of NightWare for PTSD With Nightmares (Completed, started 2019-05-21)
- NCT03795987: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) (Completed, started 2019-02-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nightware, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Nightware, Inc.”, 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 Nightware, Inc.?
The most frequent FDA product codes under this applicant name are QMZ (Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions, 1).
Next steps
- See all 0 Nightware, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QMZ, Nightware, Inc.'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.