Oktas: FDA clearances and approvals
Oktas has 7 FDA 510(k) clearances (first 1994, latest 1997), across 3 product codes in 3 review panels. Median 510(k) review time: 83 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
Review panels
Most recent Oktas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970369 | VISTA MINI CAMERA SYSTEM | GCJ | 1997-04-14 | 73 |
| K970214 | 3 DIMENSIONAL VIDEO ENDOSCOPE | GCJ | 1997-04-14 | 83 |
| K961182 | 3D SCOPE | GCJ | 1996-07-19 | 115 |
| K946171 | VIDEO ENDOSCOPE SYSTEM WITH ZOOM | GCJ | 1995-01-26 | 38 |
| K944254 | OKTAS STEREO VIEWING SYSTEM | FET | 1994-11-30 | 91 |
| K944256 | OKTAS INTRA-ORAL DENTAL CAMERA | EIA | 1994-11-22 | 83 |
| K941919 | OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM | FET | 1994-06-17 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Oktas.
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 Oktas have?
Oktas has 7 FDA 510(k) clearances (first 1994, latest 1997), across 3 product codes in 3 review panels.
How long does FDA take to clear Oktas's 510(k)s?
The median time from FDA receipt to decision across Oktas's cleared 510(k)s is 83 days.
What devices does Oktas make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 4); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 2); EIA (Unit, Operative Dental, 1).
Has Oktas had device recalls?
openFDA lists no recalls under a recalling firm name matching Oktas. Related entities may recall under other names.
Next steps
- See all 7 Oktas clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Oktas'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.