Omron Healthcare Co., Ltd.
Hoffman Est, IL, US
OMRON HEALTHCARE CO., LTD. appears in FDA device records in Hoffman Est, IL. FDA records list 68 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Omron Healthcare Co., Ltd. between 1991 and 2024. The busiest year on record is 2005, with 7. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 4 |
| 1994 | 3 |
| 1997 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 7 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 1 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 5 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 4 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | Substantially Equivalent | |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | NUH | Substantially Equivalent | |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | DXN | Substantially Equivalent | |
| K182120 | Maxpower Relief | NUH | Substantially Equivalent | |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K181992 | Heat Pain Pro | NUH | Substantially Equivalent | |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | DXN | Substantially Equivalent | |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | DXN | Substantially Equivalent | |
| K172079 | Avail | NUH | Substantially Equivalent | |
| K163235 | HEM-9210T | DXN | Substantially Equivalent | |
| K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K160115 | Heat Pain Pro | NUH | Substantially Equivalent | |
| K141978 | MAXPOWER RELIEF | NUH | Substantially Equivalent | |
| K142917 | BP652N (HEM-6300-Z) | DXN | Substantially Equivalent | |
| K141140 | COMP A-I-R | CAF | Substantially Equivalent | |
| K133383 | HEM-7320 | DXN | Substantially Equivalent | |
| K133379 | HEM-7311 | DXN | Substantially Equivalent | |
| K131749 | HEM-6221 | DXN | Substantially Equivalent | |
| K131742 | HEM-6131 | DXN | Substantially Equivalent | |
| K123498 | BP652N (HEM-6300-Z) | DXN | Substantially Equivalent | |
| K121932 | HEM-7200-Z (BP742) | DXN | Substantially Equivalent | |
| K120516 | LONG LIFE PADTM | GXY | Substantially Equivalent | |
| K113185 | MODEL HBP-1300 | DXN | Substantially Equivalent | |
| K110068 | MODEL PM3030 | NUH | Substantially Equivalent | |
| K110860 | COMP A-I-R | CAF | Substantially Equivalent | |
| K110501 | HEM-4030 | DXN | Substantially Equivalent | |
| K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | FLL | Substantially Equivalent | |
| K082812 | OMRON MODEL HBP-2070 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K081654 | HEM-9000AI | DXN | Substantially Equivalent | |
| K080289 | 1500 PRO | DXN | Substantially Equivalent | |
| K071645 | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S | MWI | Substantially Equivalent | |
| K063690 | COLIN PRESS MATE, MODEL BP S510 | MHX | Substantially Equivalent | |
| K062263 | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 | CAF | Substantially Equivalent | |
| K062043 | BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 | MNW | Substantially Equivalent | |
| K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 | DXN | Substantially Equivalent | |
| K060766 | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 | DPS | Substantially Equivalent | |
| K060811 | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 | CAF | Substantially Equivalent | |
| K050233 | OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI | DXN | Substantially Equivalent | |
| K052154 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC | DXN | Substantially Equivalent | |
| K052153 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL | DXN | Substantially Equivalent | |
| K051233 | OMRON MODEL 514N TYMPANIC THERMOMETER | FLL | Substantially Equivalent | |
| K042506 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M | DXN | Substantially Equivalent | |
| K042505 | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N | DXN | Substantially Equivalent | |
| K043060 | OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 | MNW | Substantially Equivalent | |
| K043018 | OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 | DXN | Substantially Equivalent | |
| K032305 | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL | DXN | Substantially Equivalent | |
| K021682 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030245 | 3004072282 | OMRON HEALTHCARE CO., LTD. | Kunotsubo 53, MUKO Kyoto 617-0002 JP | 2026 | and 2 more, listed in full below |
| 1450057 | 1450057 | Omron Healthcare, Inc. | 2895 Greenspoint Parkway, Hoffman Est, IL 60169 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNWAnalyzer, Body Composition
- PUHAnalyzer, Body Composition, Exempt
- DXQBlood Pressure Cuff
- FLLContinuous Measurement Thermometer
- DPSElectrocardiograph
- QDAElectrocardiograph Software For Over-The-Counter Use
- GXYElectrode, Cutaneous
- BYGMask, Oxygen
- ISAMassager, Therapeutic, Electric
- BZHMeter, Peak Flow, Spirometry
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
- FRIScale, Stand-On, Patient
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JEQToothbrush, Powered
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0466-06 | 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 modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philippines; UPC 73796-43600 | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. | Terminated | ||
| Z-0382-05 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain