Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450057

FEI Number

1450057

Entity Name

Omron Healthcare, Inc.

City/State/Country

Hoffman Est, IL, US

Establishment Address

2895 Greenspoint Parkway, Hoffman Est, IL 60169, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Omron Healthcare, Inc. (Owner Number: 10023760)

Owner / Operator Contact Address

2895 Greenspoint Parkway, Suite 100, Hoffman Estates, IL 60169, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182166

PMA Number

N/A

All Registered Proprietary Names

BP6100 (BP6100C) RC212 BCM-500 (HBF-222T-Z) HBF-516B HBF-514C HBF-510W HN-290T SC-150 HBP-1300 BP653 BP654 BP652N C900 C30AC C28FL C911 C910 C30FL C915 NE-C30 BP629N 6021RELN2 HEM-9210T HEM-RXL31 HEM-RXL31-B (Extra Large cuff 17 to 20) BP9310T (HEM-7149T2-Z) PM710-L PMKBAND-L PMKNPAD PM710-M PMKBAND-M TC220(HEM-6111-TG) C803AC NE-C803 C803AT C803NEB RE-C800KD BP6000 H-CL22 H-CL22CAN BP710N BP710CANN HEM-7311 BP742N BP765CAN-CD6 BP742CANN CD-CS9 BP765 CD-WR17 HEM-741CRELN4 BP710NVA HEM-9200T HEM-ADPTW5 BP765CAN BP7100 (BP7100C) BP7200 (HEM-7150-Z) BP5450 (HEM-7343T-Z) BP5100 (BP5100C) BP7100CAN (HEM-7121-CA) BP7250 (BP7250C) BP5350 (HEM-7341T-Z) BP7250CAN (HEM-7150T-CA) BP7110VA BP9300T (HEM-7145T2-Z) BP5150 (HEM-7142T2-ZAZ) BP7255 (HEM-716CT2-Z) BP7150 (HEM-7142T2-Z) BP5000 (HEM-716CT2-Z) BCM-750 BP7000 HEM-7600T HEM-7600T-CD6 PF9940 A055ZZ C801AT C801NEB NE-C801 HEM-6410T-ZM BP8000-M HBF-306CAN HBF-306CN HBF-400CAN HBF-400 Advanced Positioning Sensor (APS) 0148 0104MAJ 0104 11-200 HEM-18 0116 H-003DS HEM-705CPN 0146Gray HEM-432CN2 PM3031 PM3031CAN PM3030 BP8000-L (HEM-6411T-ZL HEM-6410T-ZL 9911 9912 BP6350 BP4350 (BP4350C)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-12-10
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2011-06-02
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2016-03-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-02-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-02-19
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-06-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-04-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-05-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-03-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-01-22
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2026-06-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-02
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2014-07-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-09-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-12-05
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2011-06-02
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2011-06-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-02-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2011-06-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-06-02
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2011-12-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-30
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2016-06-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-04-23

Official Correspondent

Terri Ingalls

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omron Healthcare, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450057. Last updated year: 2026. Please use registration number 1450057 when referencing this establishment in official correspondence.