Cue Health, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Cue Health, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, 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 |
|---|---|---|
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cue Health, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 2 | 1 |
Review panels
- Microbiology (2)
Most recent Cue Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232643 | Cue COVID-19 Molecular Test | QWB | 2023-11-28 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220028 | De Novo | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 2023-06-06 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-05-24.
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 Cue Health, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Cue Health, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, 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 Cue Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cue Health, Inc. is 90 days.
Which FDA product codes appear under Cue Health, Inc.?
The most frequent FDA product codes under this applicant name are QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens, 2).
Next steps
- See all 1 Cue Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QWB, Cue Health, 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.