Data / Medical devices / Japan / Omron Healthcare Co., Ltd.
Omron Healthcare Co., Ltd.: FDA-registered device maker in MUKO Kyoto, Japan, 24 510(k) clearances
Omron Healthcare Co., Ltd. is registered with the FDA (registration 8030245) in MUKO Kyoto, Japan. It lists 12 device types. The FDA files 24 510(k) clearances under its listings, the newest dated October 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030245
- FEI number
- 3004072282
- Address
- Kunotsubo 53 Terado-Cho, MUKO Kyoto, Japan, 617-0002
- Owner or operator
- OMRON HEALTHCARE CO., LTD. (8030246)
- Roles
- Specification developer
- First device listed
- March 17, 1980
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2024 | DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | QXY | Unknown | Omron Healthcare, Inc. | accessdata.fda.gov |
| April 1, 2021 | K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| September 7, 2019 | K183215 | Focus TENS Therapy, Model PM710-M/-L | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| March 14, 2019 | K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 10, 2019 | K182120 | Maxpower Relief | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 9, 2018 | K181992 | Heat Pain Pro | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 8, 2018 | K182166 | Wrist Blood Pressure Monitor Model BP4350 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 2, 2018 | K182127 | Wrist Blood Pressure Monitor Model BP6100 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| October 19, 2017 | K172079 | Avail | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| April 20, 2017 | K163235 | HEM-9210T | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 22, 2016 | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| June 3, 2016 | K160115 | Heat Pain Pro | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| December 3, 2014 | K141978 | MAXPOWER RELIEF | NUH | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| September 30, 2014 | K141140 | COMP A-I-R | CAF | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| March 4, 2014 | K133383 | HEM-7320 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 16, 2014 | K133379 | HEM-7311 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| May 17, 2012 | K120516 | LONG LIFE PADTM | GXY | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| September 2, 2011 | K110860 | COMP A-I-R | CAF | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| February 23, 2007 | K062263 | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 | CAF | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| November 7, 2006 | K062043 | BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 | MNW | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| May 25, 2006 | K060811 | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 | CAF | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| September 8, 2005 | K052153 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| February 11, 2004 | K032305 | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| May 13, 1993 | K930798 | OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated October 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.