Fifth Eye, Inc.: FDA clearances and approvals
Fifth Eye, Inc. has 2 FDA 510(k) clearances (first 2021, latest 2022), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 110 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 140 |
| 2022 | 1 | 79 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Fifth Eye, Inc.'s cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNV | Adjunctive Hemodynamic Indicator With Decision Point | 3 | 2 |
Review panels
- Cardiovascular (3)
Most recent Fifth Eye, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221203 | AHI System | QNV | 2022-07-14 | 79 |
| K212219 | AHI System | QNV | 2021-12-03 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200022 | De Novo | Adjunctive Hemodynamic Indicator With Decision Point | 2021-03-01 |
Recalls
openFDA lists no recalls under a recalling firm named Fifth Eye, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Fifth Eye, Inc. have?
Fifth Eye, Inc. has 2 FDA 510(k) clearances (first 2021, latest 2022), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Fifth Eye, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fifth Eye, Inc.'s cleared 510(k)s is 110 days.
What devices does Fifth Eye, Inc. make?
Its most frequent FDA product codes are QNV (Adjunctive Hemodynamic Indicator With Decision Point, 3).
Has Fifth Eye, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fifth Eye, Inc. Related entities may recall under other names.
Next steps
- See all 2 Fifth Eye, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QNV, Fifth Eye, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.