EDAN SA-10 Ambulatory Blood Pressure Monitor with Analysis Software

The EDAN SA-10 is a 24-hour ambulatory blood pressure monitor (ABPM) designed to record systolic and diastolic blood pressure and pulse over a programmed monitoring period, then transfer the stored measurements to a PC for clinician review and analysis. It is FDA-cleared under 510(k) K210139 (October 1, 2021) as part of the SA-series ambulatory blood pressure monitor family, classified as Class II, Product Code DXN (21 CFR 870.1130) .

The cleared intended use states the device is capable of measuring systolic and diastolic blood pressures and pulse of adults and pediatrics (>12 years) over a preprogrammed period of time, with measurements stored in the monitor and transferable to an analysis system via wired or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.

The SA-10 was clinically validated in a peer-reviewed study published in Blood Pressure Monitoring (2022). The study, conducted according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) , concluded that the SA-10 passed all requirements of the Universal Standard in the general population and can be recommended for clinical use. For validation criterion 1, the mean ± SD of the differences between the test device and reference readings was −0.59 ± 4.04 mmHg (systolic) / −1.79 ± 4.39 mmHg (diastolic) .

The SA-10 weighs approximately 160–170 g (without batteries) , measures 106 × 62 × 27 mm, and is powered by two AA alkaline batteries. It stores up to 300 blood pressure measurements and carries an IP22 rating for dust and water protection . The included analysis software provides day/night BP profiles, circadian analysis, statistical summaries, and pie chart analysis for reviewing the recorded data.

The SA-10 is built for clinicians who need a compact, validated ABPM recorder with analysis software for evaluating blood pressure outside the clinic setting, where office measurements alone may not reflect a patient’s typical daily pattern.

Key Features & Benefits

FDA-Cleared and Clinically Validated to AAMI/ESH/ISO Standard

The SA-10 carries FDA 510(k) clearance under K210139 for the SA-series ambulatory blood pressure monitor models . It has also been evaluated in an independent clinical validation study published in Blood Pressure Monitoring (2022), which assessed the device according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) . The study included 105 recruited subjects (97 in final analysis) and reported mean differences of −0.59 ± 4.04 / −1.79 ± 4.39 mmHg (systolic/diastolic) , with criterion 2 SD values of 3.10/3.80 mmHg. The authors concluded the SA-10 passed all requirements of the Universal Standard and can be recommended for clinical use.

24-Hour Recording with 300-Measurement Memory

The SA-10 is designed to record blood pressure and pulse over a preprogrammed monitoring period, storing up to 300 measurements in onboard memory . This capacity supports typical 24-hour ABPM protocols with programmed intervals, allowing the clinician to review a full day’s blood pressure profile after the wear period.

Oscillometric Measurement with Motion Resistance

The SA-10 uses the oscillometric method with step deflation for non-invasive blood pressure measurement . EDAN’s proprietary algorithm is described as offering excellent motion resistance performance, with auto re-measurement on failed measurement attempts and data protection from power outage—features intended to support data continuity during ambulatory wear .

Wide Measurement Range

The SA-10 has a blood pressure measurement range of 10 mmHg to 290 mmHg, supporting use across a broad range of adult and pediatric (>12 years) presentations .

Compact and Lightweight for Daily Wear

At approximately 160–170 g without batteries and 106 × 62 × 27 mm, the SA-10 is designed for patient comfort during a full day of wear . The IP22 rating provides protection against dust and water, supporting routine use in home and clinical settings.

Analysis Software for Comprehensive Review

The included analysis software (referred to as Smart ABPM View in FDA documentation) supports clinician review of recorded data. Features described in EDAN literature and product documentation include day/night BP profiles, circadian analysis, statistical summaries, and pie chart analysis—tools intended to help identify periods when blood pressure values are above configured limits and to summarize measurement trends throughout the day . The software allows clinicians to edit, display, and analyze the recorded data, and the ABPM function is described as providing longitudinal blood pressure data to assist physicians in managing hypertension or other cardiovascular conditions .

Wired and Wireless Data Transfer

Stored measurements can be transferred to the analysis system via USB or Bluetooth . An optional Bluetooth module is available for configurations requiring wireless transfer.

Flexible Cuff Options

The SA-10 supports reusable adult cuffs in multiple sizes: XS (16–21.5 cm) , S (20.5–28 cm) , M (27–35 cm) , and L (34–43 cm) . The size M cuff is included as standard, with other sizes available separately. Four cuff sizes were used in the clinical validation study, covering arm circumferences from 16 cm to 43 cm .

Technical Specifications

Why Choose the EDAN SA-10?