Omron Electronics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Omron Electronics, Inc.” (first 1987, latest 1990), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
Review panels
- Cardiovascular (4)
- General Hospital (4)
- Physical Medicine (2)
Most recent Omron Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902255 | OMRON PULSE STIMULATOR MODEL HV-F05 | IPF | 1990-10-31 | 163 |
| K894563 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F | DXN | 1990-03-06 | 228 |
| K893029 | OMRON TRAVEL MASSAGER, MODEL HM-01 | ISA | 1989-05-31 | 37 |
| K881415 | OMRON DIGITAL FEVER THERMOMETER MODEL MC-3 | FLL | 1988-10-04 | 183 |
| K882393 | DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP | DXN | 1988-08-30 | 81 |
| K881269 | OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C | DXN | 1988-06-16 | 84 |
| K872527 | OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B | FLL | 1987-07-23 | 28 |
| K871888 | DIGITAL FEVER THERMOMETER MODEL MC-5 | FLL | 1987-06-17 | 34 |
| K871207 | OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C | DXN | 1987-05-28 | 64 |
| K870956 | OMRON DIGITAL FEVER THERMOMETER MODEL MC-7 | FLL | 1987-04-16 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Omron Electronics, 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.
- Omron Healthcare, Inc. (68 510(k)s)
- Omron Tateisi Electronics Co. (7 510(k)s)
- Omron Marshall Products, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omron Electronics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Omron Electronics, Inc.” (first 1987, latest 1990), across 4 product codes in 3 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 Omron Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omron Electronics, Inc. is 72 days.
Which FDA product codes appear under Omron Electronics, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); FLL (Continuous Measurement Thermometer, 4); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 10 Omron Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Omron Electronics, 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.