Omron Healthcare, Inc.: FDA clearances and approvals
Omron Healthcare, Inc. has 68 FDA 510(k) clearances (first 1991, latest 2026), plus 1 De Novo decision, across 12 product codes in 7 review panels. Median 510(k) review time: 108 days. Since 2017 its median was 106 days, against 181 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Omron Healthcare, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 86 |
| 2013 | 3 | 115 |
| 2014 | 5 | 120 |
| 2015 | 0 | — |
| 2016 | 2 | 126 |
| 2017 | 3 | 113 |
| 2018 | 4 | 89 |
| 2019 | 4 | 166 |
| 2020 | 0 | — |
| 2021 | 1 | 237 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 93 |
Review time against the same product codes
Since 2017, Omron Healthcare, Inc.'s cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 37 | 37 |
| CAF | Nebulizer (Direct Patient Interface) | 7 | 7 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 7 | 7 |
| MNW | Analyzer, Body Composition | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| ISA | Massager, Therapeutic, Electric | 3 | 3 |
| JEQ | Toothbrush, Powered | 2 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (42)
- Neurology (8)
- Anesthesiology (7)
- Gastroenterology and Urology (4)
- General Hospital (3)
- Physical Medicine (3)
- Dental (2)
Most recent Omron Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | DXN | 2026-09-10 | 93 |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | 2021-04-01 | 237 |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | NUH | 2019-09-07 | 292 |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | DXN | 2019-04-17 | 30 |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | 2019-03-14 | 176 |
| K182120 | Maxpower Relief | NUH | 2019-01-10 | 157 |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | DXN | 2018-11-09 | 60 |
| K181992 | Heat Pain Pro | NUH | 2018-11-09 | 106 |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | DXN | 2018-11-08 | 90 |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | DXN | 2018-11-02 | 88 |
58 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230076 | De Novo | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature | 2024-10-08 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-10-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Omron Healthcare, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05599308: Evaluation of Blood Pressure Monitor With AFib Screening Feature (Completed, started 2022-09-06)
- NCT03130686: A Clinical Evaluation of Omron Digital Blood Pressure Monitor (Completed, started 2015-12-21)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Omron Healthcare, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Omron Healthcare, Inc. have?
Omron Healthcare, Inc. has 68 FDA 510(k) clearances (first 1991, latest 2026), plus 1 De Novo decision, across 12 product codes in 7 review panels.
How long does FDA take to clear Omron Healthcare, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Omron Healthcare, Inc.'s cleared 510(k)s is 108 days. Since 2017: 106 days, versus 181 days for all cleared 510(k)s in the same product codes.
What devices does Omron Healthcare, Inc. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 37); CAF (Nebulizer (Direct Patient Interface), 7); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 7).
Has Omron Healthcare, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Omron Healthcare, Inc; the most recent began 2005-10-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 68 Omron Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Omron Healthcare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.