Lloyds LBPK1

Device Name:

LBPK1

Manufacturer:

Brand: Lloyds Pharmacy, Sapphire Court, Walsgrave Triangle, Coventry CV2 2TX, UNITED KINGDOM.

Distributer: Harvard Medical Devices Limited, Unit 1301-02, 13th Floor, Railway Plaza, 39 Chatham Road South, Tsimshatsui, Kowloon, HONG KONG PRC.

Other: Kinetik Medical Devices Limited, Lockeridge House, Lockeridge, Marlborough, Wiltshire SN8 4EL, UNITED KINGDOM.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Device Manual:

Click here to download the Device Manual

Description:

The Lloyds LBPK1 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 upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

While the technology used in the Lloyds LBPK1, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Previous recommendation, now archived (Archived)	Manufacturer declaration of equivalence to the Kinetik BPM1 Series without published evidence
BP	ESH (Europe)	Self-measurement	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.

Device Family:

Kinetik BPM1CB, Kinetik BPM1KTLB, Kinetik BPM1KB, Lloyds LBP1B, Lloyds LBPK1B
Legend: B BIHS Derivative

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.

Kinetik BPM1C

Schwartz CL, Edwards K, Gamble W, Kirkham A, Lacy P, Lewis P, McDonagh STJ, Peers C, Sheppard JP, Swales P, Howarth J, Williams B. Validation of the Kinetik Blood Pressure Monitor-Series 1 for use in adults at home and in clinical settings, according to the 2002 European Society of Hypertension International Protocol on the validation of blood pressure devices. J Hum Hypertens. 2021 Nov;35(11):1046-1050. Epub: 2020 Nov 22. doi: 10.1038/s41371-020-00445-9. PMID: 33223524.

ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)