Omega Medical Electronics: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Omega Medical Electronics” (first 1982, latest 1983), across 21 product codes in 2 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHD | Acid, Ferric Ion-Sulfuric, Cholesterol | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (20)
- Hematology (1)
Most recent Omega Medical Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823691 | PHOSPHORUS REAGENT SET | CEO | 1983-01-07 | 30 |
| K821212 | UREA NITROGEN REAGENT SET | CDW | 1982-07-22 | 86 |
| K821206 | SGPT-UV REAGENT SET | CKA | 1982-07-22 | 86 |
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | CGA | 1982-07-22 | 86 |
| K821208 | SGOT-UV REAGENT SET | CIT | 1982-07-20 | 84 |
| K821205 | TRIGLYCERIDE REAGENT SET | CDT | 1982-07-20 | 84 |
| K821201 | LDH-UV REAGENT SET | CFJ | 1982-07-20 | 84 |
| K821209 | SGOT REAGENT SET | CIQ | 1982-07-14 | 78 |
| K821207 | SGPT REAGENT SET | CKD | 1982-07-14 | 78 |
| K821213 | URIC ACID REAGENT SET | CDH | 1982-07-13 | 77 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Omega Medical Electronics.
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 Imaging, Inc. (15 510(k)s)
- Omega Laboratories, Inc. (9 510(k)s)
- Omega Medical Diagnostics (5 510(k)s)
- Omega Silicone, Inc. (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 Medical Electronics?
FDA lists 21 510(k) clearances under the applicant name “Omega Medical Electronics” (first 1982, latest 1983), across 21 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 Medical Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega Medical Electronics is 77 days.
Which FDA product codes appear under Omega Medical Electronics?
The most frequent FDA product codes under this applicant name are CDH (Acid, Uric, Phosphotungstate Reduction, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1).
Next steps
- See all 21 Omega Medical Electronics clearances with predicates and recalls
- Run predicate analysis for product code CDH, Omega Medical Electronics'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.