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Spacelabs OnTrak (90227)
Device Name:
Device Model:
Spacelabs Healthcare, 35301 SE Center St., Snoqualmie, WA 98065, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Available Currently
Availability according to Countries or Regions:
Device Specifications:
The Spacelabs OnTrak (90227) is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
The technology used in the Spacelabs OnTrak (90227), 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.
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) ABPM Published evidence
BP Hypertension Canada ABPM (Gold) Published evidence
BP Stride BP ABPM for adults (Preferred) Published evidence
BP FDA (US) 510(k) 510(k) K141113
Validation Publications:

de Greeff A, Shennan AH. Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols. Blood Press Monit. 2020 Apr;25(2):110-114. Epub: 2019 Dec 10. doi: 10.1097/MBP.0000000000000424. PMID: 31833949.

81060-2:2013 - Pass General population

ESH-IP:2010 - Pass General population

BHS:1993 - Pass (A/A) General population