Omron Tateisi Electronics Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Omron Tateisi Electronics Co.” (first 1985, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 97 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 | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
Most recent Omron Tateisi Electronics Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881602 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C | DXN | 1988-06-15 | 63 |
| K881601 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C | DXN | 1988-06-15 | 63 |
| K871371 | DIGITAL SPHYGMOMANOMETER | DRS | 1987-06-12 | 66 |
| K864466 | OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 | CAF | 1987-03-26 | 134 |
| K854201 | OMRON DIGITAL BP MONITOR HEM-700CP | DXN | 1986-04-17 | 184 |
| K853260 | OMRON DIGITAL BP MONITOR HEM-700C | DXN | 1985-11-18 | 108 |
| K851707 | OMRON DIGITAL BP MONITOR HEM-400C | DXN | 1985-07-31 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Omron Tateisi Electronics Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Omron Tateisi Electronics Co. (a text match, not an official crosswalk):
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 Electronics, Inc. (10 510(k)s)
- Omron Marshall Products, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omron Tateisi Electronics Co.?
FDA lists 7 510(k) clearances under the applicant name “Omron Tateisi Electronics Co.” (first 1985, latest 1988), across 3 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 Omron Tateisi Electronics Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omron Tateisi Electronics Co. is 97 days.
Which FDA product codes appear under Omron Tateisi Electronics Co.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5); CAF (Nebulizer (Direct Patient Interface), 1); DRS (Transducer, Blood-Pressure, Extravascular, 1).
Next steps
- See all 7 Omron Tateisi Electronics Co. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Omron Tateisi Electronics Co.'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.