Welch Allyn Connex ProBP 3400 with SureBP

Description:

The Welch Allyn Connex ProBP 3400 with SureBP is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for professional use. DO NOT USE THIS DEVICE. It has been recalled by the manufacturer. Please check with your supplier or the manufacturer for further details.

Assessment:

The technology used in the Welch Allyn Connex ProBP 3400 with SureBP, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	BIHS (UK and IRL)	Professional use	Published evidence
BP	ESH (Europe)	Professional use for adults and children	Published evidence
BP	AMA VDL (US)	Office use (Recall noted)	Published evidence plus 510(k) K101680
BP	FDA (US)	510(k)	510(k) K101680

Device Family:

Welch Allyn Connex ProBP 3400 with SureBPA, Hillrom Connex Vital Signs 6000 SeriesA, Welch Allyn SureBP Algorithm (Unspecified Device)A, Hillrom Connex SpotA, Hillrom Spot Vital Signs 4400A
Legend: A Same validated algorithm

Validation Publications:

Alpert BS. Validation of the Welch Allyn ProBP 3400: a device for modern medical practice. Blood Press Monit. 2011 Jun;16(3):156-8. doi: 10.1097/MBP.0b013e328346d61b. PMID: 21527848.

SP10:2002 - Pass General population (Note: Cirterion 1 only (n=92))

Relevant Publications:

Harfmann BD, Neph SE, Gardner MM, Plouffe AA, Vranish JR, Montoye AHK. Comparison of the Omron HeartGuide to the Welch Allyn ProBP 3400 blood pressure monitor. Blood Press Monit. 2024 Feb 1;29(1):45-54. Epub: 2023 Sep 14. doi: 10.1097/MBP.0000000000000672. PMID: 37702590.

Measurements from the Welch Allyn Connex ProBP 3400 are compared to those from the Omron HeartGuide, though not in a formal validation.

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.

Welch Allyn SureBP Algorithm (Unspecified Device)

Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.

SP10:2006 - Pass General population