Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omron Healthcare, Inc. · Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
280 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) | Omron Healthcare, Inc. | 2024-10-08 | 330 | 0 |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2021-04-01 | 237 | 0 |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | Omron Healthcare, Inc. | 2019-09-07 | 292 | 0 |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2019-04-17 | 30 | 0 |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2019-03-14 | 176 | 0 |
| K182120 | Maxpower Relief | Omron Healthcare, Inc. | 2019-01-10 | 157 | 0 |
| K181992 | Heat Pain Pro | Omron Healthcare, Inc. | 2018-11-09 | 106 | 0 |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2018-11-09 | 60 | 0 |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare, Inc. | 2018-11-08 | 90 | 0 |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | 2018-11-02 | 88 | 0 |
| K172079 | Avail | Omron Healthcare, Inc. | 2017-10-19 | 101 | 0 |
| K163235 | HEM-9210T | Omron Healthcare, Inc. | 2017-04-20 | 154 | 0 |
| K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2017-02-21 | 113 | 0 |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare, Inc. | 2016-11-22 | 117 | 0 |
| K160115 | Heat Pain Pro | Omron Healthcare, Inc. | 2016-06-03 | 136 | 0 |
| K141978 | MAXPOWER RELIEF | Omron Healthcare, Inc. | 2014-12-03 | 135 | 0 |
| K142917 | BP652N (HEM-6300-Z) | Omron Healthcare, Inc. | 2014-12-01 | 55 | 0 |
| K141140 | COMP A-I-R | Omron Healthcare, Inc. | 2014-09-30 | 151 | 0 |
| K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014-03-04 | 120 | 0 |
| K133379 | HEM-7311 | Omron Healthcare, Inc. | 2014-01-16 | 73 | 0 |
| K131749 | HEM-6221 | Omron Healthcare, Inc. | 2013-10-07 | 115 | 0 |
| K131742 | HEM-6131 | Omron Healthcare, Inc. | 2013-07-24 | 41 | 0 |
| K123498 | BP652N (HEM-6300-Z) | Omron Healthcare, Inc. | 2013-03-21 | 128 | 0 |
| K121932 | HEM-7200-Z (BP742) | Omron Healthcare, Inc. | 2012-08-29 | 58 | 0 |
| K120516 | LONG LIFE PADTM | Omron Healthcare, Inc. | 2012-05-17 | 86 | 0 |
| K113185 | MODEL HBP-1300 | Omron Healthcare, Inc. | 2012-01-27 | 91 | 0 |
| K110068 | MODEL PM3030 | Omron Healthcare, Inc. | 2011-12-08 | 332 | 0 |
| K110860 | COMP A-I-R | Omron Healthcare, Inc. | 2011-09-02 | 157 | 0 |
| K110501 | HEM-4030 | Omron Healthcare, Inc. | 2011-03-21 | 27 | 0 |
| K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | Omron Healthcare, Inc. | 2009-09-01 | 84 | 0 |
| K082812 | OMRON MODEL HBP-2070 VITAL SIGNS MONITOR | Omron Healthcare, Inc. | 2008-10-22 | 28 | 0 |
| K081654 | HEM-9000AI | Omron Healthcare, Inc. | 2008-10-10 | 120 | 0 |
| K080289 | 1500 PRO | Omron Healthcare, Inc. | 2008-02-26 | 22 | 0 |
| K071645 | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S | Omron Healthcare, Inc. | 2007-07-02 | 17 | 0 |
| K063690 | COLIN PRESS MATE, MODEL BP S510 | Omron Healthcare, Inc. | 2007-05-09 | 148 | 0 |
| K062263 | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 | Omron Healthcare, Inc. | 2007-02-23 | 203 | 0 |
| K062043 | BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 | Omron Healthcare, Inc. | 2006-11-07 | 111 | 0 |
| K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MOD | Omron Healthcare, Inc. | 2006-08-02 | 35 | 0 |
| K060766 | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 | Omron Healthcare, Inc. | 2006-06-09 | 79 | 0 |
| K060811 | OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 | Omron Healthcare, Inc. | 2006-05-25 | 62 | 0 |
| K050233 | OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION | Omron Healthcare, Inc. | 2005-10-28 | 269 | 0 |
| K052154 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC | Omron Healthcare, Inc. | 2005-09-08 | 30 | 0 |
| K052153 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL | Omron Healthcare, Inc. | 2005-09-08 | 30 | 0 |
| K051233 | OMRON MODEL 514N TYMPANIC THERMOMETER | Omron Healthcare, Inc. | 2005-06-21 | 39 | 0 |
| K042505 | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N | Omron Healthcare, Inc. | 2005-04-05 | 202 | 0 |
| K042506 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M | Omron Healthcare, Inc. | 2005-04-05 | 202 | 0 |
| K043060 | OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 | Omron Healthcare, Inc. | 2005-01-19 | 75 | 0 |
| K043018 | OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 | Omron Healthcare, Inc. | 2004-11-10 | 8 | 0 |
| K032305 | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM | Omron Healthcare, Inc. | 2004-02-11 | 201 | 0 |
| K021682 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MO | Omron Healthcare, Inc. | 2002-12-12 | 204 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda