Omega Silicone, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Omega Silicone, Inc.” (first 1987, latest 1987), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 54 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 | 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| FYI | Appliance, Facial Fracture, External | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| LFB | Button, Nasal Septal | 1 | 1 |
Review panels
Most recent Omega Silicone, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871072 | OMEGA NASAL SEPTAL BUTTON | LFB | 1987-06-08 | 82 |
| K871073 | OMEGA BIVALVE NASAL SPLINTS | FYI | 1987-05-11 | 54 |
| K871070 | OMEGA SILICONE CHIN IMPLANT | FWP | 1987-05-11 | 54 |
| K871071 | OMEGA DORSAL COLUMELLA IMPLANTS | FZE | 1987-04-13 | 26 |
| K871074 | OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR | FWP | 1987-04-10 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Omega Silicone, 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.
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.
- Omega Medical Electronics (21 510(k)s)
- Omega Medical Imaging, Inc. (15 510(k)s)
- Omega Laboratories, Inc. (9 510(k)s)
- Omega Medical Diagnostics (5 510(k)s)
- Omega Surgical Instruments, Inc. (3 510(k)s)
- Omega Universal Technologies, Ltd. (3 510(k)s)
- Omega Medical Corp. (2 510(k)s)
- Omega Critical Care Limited (1 510(k)s)
- Omega Group, Inc. (1 510(k)s)
- Omega Hearing Aid Center (1 510(k)s)
- Omega Mark-3 Pen Corp. (1 510(k)s)
- Omega Medical Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omega Silicone, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Omega Silicone, Inc.” (first 1987, latest 1987), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omega Silicone, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega Silicone, Inc. is 54 days.
Which FDA product codes appear under Omega Silicone, Inc.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 2); FYI (Appliance, Facial Fracture, External, 1); FZE (Prosthesis, Nose, Internal, 1).
Next steps
- See all 5 Omega Silicone, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Omega Silicone, 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.