Company ยท US
Omron Healthcare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.
69510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 37 |
| CAF | Nebulizer (Direct Patient Interface) | 8 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 7 |
| FLL | Continuous Measurement Thermometer | 4 |
| MNW | Analyzer, Body Composition | 4 |
| ISA | Massager, Therapeutic, Electric | 3 |
| JEQ | Toothbrush, Powered | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 |
| DPS | Electrocardiograph | 1 |
| GXY | Electrode, Cutaneous | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 |
| QXY | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2026 | K261929 | Upper Arm Blood pressure monitor (BP7155D) OMRON Healthcare, Inc. | DXN |
| Oct 8, 2024 | DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pre Omron Healthcare, Inc. | QXY |
| Apr 1, 2021 | K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc. | DXN |
| Sep 7, 2019 | K183215 | Focus TENS Therapy, Model PM710-M/-L Omron Healthcare, Inc. | NUH |
| Apr 17, 2019 | K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor Omron Healthcare, Inc. | DXN |
| Mar 14, 2019 | K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc. | DXN |
| Jan 10, 2019 | K182120 | Maxpower Relief Omron Healthcare, Inc. | NUH |
| Nov 9, 2018 | K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor Omron Healthcare, Inc. | DXN |
| Nov 9, 2018 | K181992 | Heat Pain Pro Omron Healthcare, Inc. | NUH |
| Nov 8, 2018 | K182166 | Wrist Blood Pressure Monitor Model BP4350 Omron Healthcare, Inc. | DXN |
| Nov 2, 2018 | K182127 | Wrist Blood Pressure Monitor Model BP6100 Omron Healthcare, Inc. | DXN |
| Oct 19, 2017 | K172079 | Avail Omron Healthcare, Inc. | NUH |
| Apr 20, 2017 | K163235 | HEM-9210T Omron Healthcare, Inc. | DXN |
| Feb 21, 2017 | K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor Omron Healthcare, Inc. | DXN |
| Nov 22, 2016 | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor Omron Healthcare, Inc. | DXN |
| Jun 3, 2016 | K160115 | Heat Pain Pro Omron Healthcare, Inc. | NUH |
| Dec 3, 2014 | K141978 | MAXPOWER RELIEF Omron Healthcare, Inc. | NUH |
| Dec 1, 2014 | K142917 | BP652N (HEM-6300-Z) Omron Healthcare, Inc. | DXN |
| Sep 30, 2014 | K141140 | COMP A-I-R Omron Healthcare, Inc. | CAF |
| Mar 4, 2014 | K133383 | HEM-7320 Omron Healthcare, Inc. | DXN |
| Jan 16, 2014 | K133379 | HEM-7311 Omron Healthcare, Inc. | DXN |
| Oct 7, 2013 | K131749 | HEM-6221 Omron Healthcare, Inc. | DXN |
| Jul 24, 2013 | K131742 | HEM-6131 Omron Healthcare, Inc. | DXN |
| Mar 21, 2013 | K123498 | BP652N (HEM-6300-Z) Omron Healthcare, Inc. | DXN |
| Aug 29, 2012 | K121932 | HEM-7200-Z (BP742) Omron Healthcare, Inc. | DXN |
| May 17, 2012 | K120516 | LONG LIFE PADTM Omron Healthcare, Inc. | GXY |
| Jan 27, 2012 | K113185 | MODEL HBP-1300 Omron Healthcare, Inc. | DXN |
| Dec 8, 2011 | K110068 | MODEL PM3030 Omron Healthcare, Inc. | NUH |
| Sep 2, 2011 | K110860 | COMP A-I-R Omron Healthcare, Inc. | CAF |
| Mar 21, 2011 | K110501 | HEM-4030 Omron Healthcare, Inc. | DXN |
| Sep 1, 2009 | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 Omron Healthcare, Inc. | FLL |
| Oct 22, 2008 | K082812 | OMRON MODEL HBP-2070 VITAL SIGNS MONITOR Omron Healthcare, Inc. | MWI |
| Oct 10, 2008 | K081654 | HEM-9000AI Omron Healthcare, Inc. | DXN |
| Feb 26, 2008 | K080289 | 1500 PRO Omron Healthcare, Inc. | DXN |
| Jul 2, 2007 | K071645 | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S Omron Healthcare, Inc. | MWI |
| May 9, 2007 | K063690 | COLIN PRESS MATE, MODEL BP S510 Omron Healthcare, Inc. | MHX |
| Feb 23, 2007 | K062263 | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 Omron Healthcare, Inc. | CAF |
| Nov 7, 2006 | K062043 | BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 Omron Healthcare, Inc. | MNW |
| Aug 2, 2006 | K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 Omron Healthcare, Inc. | DXN |
| Jun 9, 2006 | K060766 | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 Omron Healthcare, Inc. | DPS |
| May 25, 2006 | K060811 | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 Omron Healthcare, Inc. | CAF |
| Oct 28, 2005 | K050233 | OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI Omron Healthcare, Inc. | DXN |
| Sep 8, 2005 | K052154 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC Omron Healthcare, Inc. | DXN |
| Sep 8, 2005 | K052153 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL Omron Healthcare, Inc. | DXN |
| Jun 21, 2005 | K051233 | OMRON MODEL 514N TYMPANIC THERMOMETER Omron Healthcare, Inc. | FLL |
| Apr 5, 2005 | K042506 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M Omron Healthcare, Inc. | DXN |
| Apr 5, 2005 | K042505 | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N Omron Healthcare, Inc. | DXN |
| Jan 19, 2005 | K043060 | OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 Omron Healthcare, Inc. | MNW |
| Nov 10, 2004 | K043018 | OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 Omron Healthcare, Inc. | DXN |
| Feb 11, 2004 | K032305 | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL Omron Healthcare, Inc. | DXN |
Newest 50 of 69.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2006 | Omron Healthcare, Inc. 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, Terminated |
FLL | K983887 |
| Jan 5, 2005 | Omron Healthcare, Inc. 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 Terminated |
CAF | K923024 |