Data / Medical devices / United States / Omron Healthcare, Inc.
Omron Healthcare, Inc.: FDA-registered device maker in Hoffman Est, IL, United States, 47 510(k) clearances
Omron Healthcare, Inc. is registered with the FDA (registration 1450057) in Hoffman Est, IL, United States. It lists 17 device types. The FDA files 47 510(k) clearances under its listings, the newest dated September 10, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450057
- Address
- 2895 Greenspoint Parkway, Hoffman Est, IL, United States, 60169
- Owner or operator
- Omron Healthcare, Inc. (10023760)
- Roles
- Repackager or relabeler
- First device listed
- June 2, 2011
- Registered through
- 2026
- Brand names listed
- 0104, 0104MAJ, 0116, 0146Gray, 0148, 11-200, 6021RELN2, 7400RELN and more
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 |
|---|---|---|---|---|---|---|
| September 10, 2026 | K261929 | Upper Arm Blood pressure monitor (BP7155D) | DXN | Substantially Equivalent | OMRON Healthcare, Inc. | accessdata.fda.gov |
| 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 |
| April 17, 2019 | K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | DXN | 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 | K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | DXN | 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 |
| February 21, 2017 | K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | 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 |
| December 1, 2014 | K142917 | BP652N (HEM-6300-Z) | DXN | 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 |
| July 24, 2013 | K131742 | HEM-6131 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| March 21, 2013 | K123498 | BP652N (HEM-6300-Z) | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| August 29, 2012 | K121932 | HEM-7200-Z (BP742) | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| July 17, 2012 | K121428 | NON-CONTACT CLINICAL THERMOMETER | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| May 17, 2012 | K120516 | LONG LIFE PADTM | GXY | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 27, 2012 | K113185 | MODEL HBP-1300 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| December 8, 2011 | K110068 | MODEL PM3030 | NUH | 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 |
| August 2, 2006 | K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| June 9, 2006 | K060766 | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 | DPS | 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 |
| April 5, 2005 | K042506 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| April 5, 2005 | K042505 | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 19, 2005 | K043060 | OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 | MNW | 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 |
| July 9, 2002 | K013434 | VP-2000/1000 | DXN | Substantially Equivalent | Colin Corp. | accessdata.fda.gov |
| November 7, 2001 | K011652 | BODY FAT ANALYZER, MODEL HBF-306 | MNW | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| June 30, 2000 | K001671 | ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1999 | K982334 | AIRZONE PEAK FLOWMETER | BZH | Substantially Equivalent | Clement Clarke Intl., Ltd. | accessdata.fda.gov |
| May 13, 1993 | K930798 | OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| January 18, 1991 | K903133 | OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C | DXN | Substantially Equivalent | Omron Marshall Products, Inc. | accessdata.fda.gov |
| March 16, 1987 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| July 17, 1978 | K780715 | ANEROID TYPE BLOOD PRESSURE KIT | DXQ | Substantially Equivalent | Mars Metal Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 25, 2005 | 33801 | Not yet classified | Terminated | Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm m | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. | accessdata.fda.gov |
| November 2, 2004 | 30363 | Not yet classified | Terminated | Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061 | A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization. | accessdata.fda.gov |
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Updated September 10, 2026. 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.