Omron BP6100 (HEM-6180-Z)

Device Name:

BP6100

Device Model:

HEM-6180-Z

Manufacturer:

Brand: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Distributer: OMRON Healthcare Inc., 1925 West Field Court, Lake Forest, Illinois 60045, UNITED STATES.

Other: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

United States

Device Manual:

Click here to download the Device Manual

Description:

The Omron BP6100 (HEM-6180-Z) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the Omron BP6100 (HEM-6180-Z), to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	AMA VDL (US)	Self-measurement	Implied equivalence to the Omron HEM-6181 plus 510(k) K182127
BP	FDA (US)	510(k)	510(k) K182127

	Consumer Body	Year(s)	Level	Comment
BP	Consumer Reports (US)	Latest: 2021	Very Good

Device Family:

Omron HEM-6131F, Omron BP652N (HEM-6300-Z)F, Omron HeartGuide (HEM-6411T-MAE)P, Omron Heartguide BP8000-M (HEM-6410T-ZM)P,F, Omron BP4350 (HEM-6232T-Z) GoldF, Omron BP6100 (HEM-6180-Z)F
Legend: P Stride Equivalence, F FDA 510(k)

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron Heartguide BP8000-M (HEM-6410T-ZM)

Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens (Greenwich). 2019 Jun;21(6):853-858. Epub: 2019 Feb 25. doi: 10.1111/jch.13499. PMID: 30803128.

81060-2:2013 - Pass General population