Owandy: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Owandy” (first 2006, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 150 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 113 |
| 2014 | 1 | 186 |
| 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 4 | 4 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
- Radiology (6)
Most recent Owandy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133271 | OPTEO, VIDEOGRAPH HD | MUH | 2014-04-28 | 186 |
| K130443 | I-MAX TOUCH 3D | OAS | 2013-06-14 | 113 |
| K093105 | VISTEO | EHD | 2010-10-18 | 382 |
| K083057 | I-MAX TOUCH | MUH | 2009-06-02 | 231 |
| K070505 | KRYSTAL-X WIFI | MUH | 2007-04-05 | 43 |
| K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | MUH | 2006-11-14 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Owandy.
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.
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.
- Owandy Sas (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Owandy?
FDA lists 6 510(k) clearances under the applicant name “Owandy” (first 2006, latest 2014), across 3 product codes 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 Owandy?
The median time from FDA receipt to decision across 510(k)s cleared under the name Owandy is 150 days.
Which FDA product codes appear under Owandy?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 4); EHD (Unit, X-Ray, Extraoral With Timer, 1); OAS (X-Ray, Tomography, Computed, Dental, 1).
Next steps
- See all 6 Owandy clearances with predicates and recalls
- Run predicate analysis for product code MUH, Owandy'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.