# Omron Healthcare, Inc.

- Location (FDA's records): Bonita Springs, FL
- FDA decisions: 69 (1991–2026): 68 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Omron Healthcare, Inc. (68); OMRON Healthcare, Inc. (1)
- Product codes: DXN (37), CAF (7), NUH (7), MNW (4), FLL (3), ISA (3), MWI (2), JEQ (2), MHX (1), DPS (1), QXY (1), GXY (1)
- 510(k) review time since 2016: median 113 days, against 184 for FDA's reviews in the same codes and years (12 of 15 faster)
- Predicates its devices cite: 51 (35 its own); citations of its devices by later devices: 145 (35 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Atcor Medical: 3 (https://510kreport.com/company/atcor-medical)
- AliveCor, Inc.: 2 (https://510kreport.com/company/alivecor)
- Colin Medical Instruments Corp.: 2 (https://510kreport.com/company/colin-medical-instruments)
- Ormon Electronics, Inc.: 1 (https://510kreport.com/company/ormon-electronics)
- Healthmate International, LLC: 1 (https://510kreport.com/company/healthmate-international)
- Endurance Therapeutics: 1 (https://510kreport.com/company/endurance-therapeutics)
- Braun GmbH: 1 (https://510kreport.com/company/braun)
- Colin Corp.: 1 (https://510kreport.com/company/colin)

## Firms that cite its devices most
- Health & Life Co., Ltd.: 5 (https://510kreport.com/company/health-life)
- Joytech Healthcare Co., Ltd.: 4 (https://510kreport.com/company/joytech-healthcare)
- Taidoc Technology Corporation: 4 (https://510kreport.com/company/taidoc-technology)
- Avita Corporation: 3 (https://510kreport.com/company/avita)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.: 3 (https://510kreport.com/company/jiangsu-yuyue-medical-equipment-supply)
- Mediana Co., Ltd.: 3 (https://510kreport.com/company/mediana)
- Healthstats International Pte., Ltd.: 2 (https://510kreport.com/company/healthstats-international)
- Biospace Corporation Limited: 2 (https://510kreport.com/company/biospace)

## Its most-cited devices
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 (2007), cited by 12
- K011652: Body Fat Analyzer, Model HBF-306 (2001), cited by 12
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801 (2006), cited by 11
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N (2005), cited by 7
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 (2006), cited by 7
- K110068: Model PM3030 (2011), cited by 6

## Recent decisions
- K261929: Upper Arm Blood pressure monitor (BP7155D) (Sep 10, 2026)
- 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)) (Oct 8, 2024)
- K202228: Omron Model BP7900 Blood Pressure Monitor + EKG (Apr 1, 2021)
- K183215: Focus TENS Therapy, Model PM710-M/-L (Sep 7, 2019)
- K190693: HEM-6410T-ZL Wrist Blood Pressure Monitor (Apr 17, 2019)
- K182579: Omron Model BP7900 Blood Pressure Monitor + EKG (Mar 14, 2019)
- K182120: Maxpower Relief (Jan 10, 2019)
- K181992: Heat Pain Pro (Nov 9, 2018)

Source page: https://510kreport.com/company/omron-healthcare