Three steps: copy the exact model number from the label, box or manual; search for it on the US Blood Pressure Validated Device Listing (validatebp.org), STRIDE BP or your country's list, where a listed model counts as a validated blood pressure monitor; then ask a clinician to compare it with clinic equipment, and repeat that yearly.
Being on sale is not proof of accuracy. A 2023 World Hypertension League policy statement estimates that 75–80% of automated blood pressure monitors marketed worldwide lack evidence of adequate clinical validation, and a 2023 review in the Journal of Human Hypertension says pre-market clearance by most regulators, which includes FDA 510(k) clearance and the CE mark, should not be taken as clinical validation.
What is a validated blood pressure monitor?
A validated blood pressure monitor is a model whose readings have been compared with reference measurements in an independent clinical study that follows a recognised protocol. The current international protocol is the AAMI/ESH/ISO Universal Standard, ISO 81060-2:2018, amended in 2020 and 2024 and now under revision. Validation covers the model, any listed equivalents, and the groups of people it was tested in, not every unit sold.
To pass the standard's main accuracy test, a monitor is tried in at least 85 people, and its readings must differ from the reference by 5 mmHg or less on average, with a standard deviation of 8 mmHg or less, for both systolic and diastolic pressure; a second, per-person criterion must also be met. Lists also accept older protocols: the US listing still takes validations back to the 1993 British Hypertension Society protocol, and STRIDE BP has required the 2018 standard only for studies submitted since January 2024. When Peprah and colleagues (2023) tested five upper-arm home monitors sold in the US, only two met the standard for the general adult population.
| Term | What it is | What it tells you |
|---|---|---|
| Regulatory clearance (FDA 510(k), CE mark) | Permission to sell | Not, on its own, proof of accuracy |
| Clinical validation | Independent study of the model in people, to a recognised protocol | The model met an accuracy standard in the groups tested |
| Calibration check | Pressure test of one unit against reference equipment | Whether that unit still measures pressure correctly |
| Clinic comparison | Your monitor alternated with a clinic device, on you | A rough sense of whether your unit agrees with the clinic's |
How do I check if my monitor is on a validated list?
Search a validated-device list for the exact model number, including every letter and suffix, as printed on the monitor's label, box or manual. Picone and colleagues' 2023 review in the Journal of Human Hypertension advises using your own country's list first where one exists, then an international list such as STRIDE BP. If the model appears, check that the entry covers home use and the people who will use the monitor.
- Copy the model number exactly. A near match is not a match.
- Search carefully. On STRIDE BP, type the exact model or manufacturer name; a University of Tasmania guide, hosted in Spanish on the PAHO website (2020), warns that a small spelling mistake can hide a validated monitor.
- Read the entry. The American Heart Association says a monitor for an older person, a pregnant person or a child should be validated for that group.
| List | Who runs it | What it covers |
|---|---|---|
| US Blood Pressure Validated Device Listing (VDL) | American Medical Association; listings decided by an Independent Review Committee of blood pressure experts, in a review managed by NORC at the University of Chicago | Monitors with active FDA 510(k) clearance and documented independent validation; manufacturers apply voluntarily |
| STRIDE BP | International non-profit affiliated with the International Society of Hypertension, European Society of Hypertension and World Hypertension League | Office, home and 24-hour devices for adults, children and pregnancy; no cuffless devices |
| British and Irish Hypertension Society | BIHS | UK and Ireland; approval after review of published validation studies |
| Hypertension Canada | Hypertension Canada | Canada; devices validated to the 2018 AAMI/ISO/ESH standard, logo on the box or leaflet |
| Medaval | Private, for-profit company, not affiliated with scientific societies | Validated and non-validated devices, so a listing there is not proof of validation |
What if my model isn't on a validated list?
A blood pressure monitor missing from a validated list has not necessarily failed testing. Manufacturers choose which lists to submit a device to, each list judges "equivalent" models differently, and identical internals are sometimes sold under another model number or brand, according to a 2023 review of validated device lists. Recheck the exact model number, search a second list, and ask a pharmacist or clinician before relying on the readings.
Guides differ on strictness: the University of Tasmania guide advises against using a monitor that cannot be found. And "listed" does not mean "accurate for you": CDC guidance for clinicians (2014) notes that even a validated device may be consistently off by ±5 mmHg in many people, especially older adults and people with diabetes.
Are wrist monitors and smartwatches validated?
Some wrist-cuff monitors are validated and listed, but guidance prefers the upper arm: Picone and colleagues (2023) recommend wrist cuffs only where an upper-arm cuff is not feasible, and STRIDE BP never marks a wrist device as "Preferred". STRIDE BP does not consider cuffless devices, which estimate blood pressure without inflating a cuff, as most smartwatches do. A watch with a small inflatable cuff in its strap is a wrist-cuff device, checked by exact model like any other.
A 2020 study in Hypertension that searched online shops selling to Australia found 18.3% of upper-arm cuff monitors, 8.0% of wrist-cuff monitors and none of 532 wrist-band wearables were validated. See how to use a wrist blood pressure monitor and can an Apple Watch measure blood pressure?
How can I check if my blood pressure monitor is accurate?
The usual way to check a home blood pressure monitor's accuracy is to have a clinician compare it with the clinic's equipment at an appointment. The American Heart Association advises having a healthcare professional confirm you use a new monitor correctly and get the same results as the office equipment, then bringing it back yearly or as the manufacturer directs.
The CDC's Million Hearts guidance for clinicians (2014) describes one method: five same-arm readings no more than 30 seconds apart, readings 1, 2 and 4 on your monitor and 3 and 5 on the clinic's.
| Difference between the two devices | What the CDC 2014 guidance says |
|---|---|
| 5 mmHg or less | The comparison is acceptable |
| More than 5 but under 10 mmHg | Repeat the comparison |
| More than 10 mmHg | The device may not be accurate |
The same guidance says there is no established target for how close the readings should be, so this is a rough check run by a clinician, not a pass mark or a home test. Readings also tend to fall across the five, with the last systolic as much as 10 mmHg below the first. List the monitor among what to bring to your appointment, and write which device took each reading in the notes of a printable log or the Monitor2Log diary, which keeps records but cannot judge accuracy.
Do blood pressure monitors lose accuracy over time?
Home blood pressure monitors can lose accuracy with age. In the ACCU-RATE study, published in the British Journal of General Practice in 2020, 331 monitors owned by patients in England were tested against a calibrated reference. Monitors in use for four years or less passed the pressure test 95% of the time, against 74% for older ones, and most faulty monitors read too high.
Validated monitors passed the pressure test 96% of the time and unvalidated ones 64%. Overall, 76% of devices passed every test of monitor and cuff; on the pressure test, a difference of 3 mmHg or more from the reference at any test pressure counted as a failure. The British and Irish Hypertension Society notes that recalibrating a home monitor can be inconvenient and expensive, and advises replacing it after at most four years of use, with a validated one.
Does the cuff that came with the monitor matter?
Yes. A blood pressure monitor's validation covers only the cuff sizes tested with that model, so a cuff never tested with it falls outside what the validation shows. Cuffs can also fail: in the ACCU-RATE study of patients' own monitors in England (2020), 12% of cuffs failed an air-leak test, and large cuffs failed more often than medium ones (26% against 10%).
If your upper arm falls outside the range printed on the cuff, look for a size the manufacturer makes for that model. Is your blood pressure cuff the right size? shows how to measure your arm.
Sources
- American Medical Association, 2024, US Blood Pressure Validated Device Listing criteria and review process.
- STRIDE BP, 2024, principles for device listing, including "Preferred" criteria.
- Journal of Human Hypertension, 2023, Picone et al., how to find and use validated blood pressure measuring devices.
- Centers for Disease Control and Prevention / Million Hearts, 2014, self-measured blood pressure action steps for clinicians.
- British Journal of General Practice, 2020, Hodgkinson et al., ACCU-RATE study of patients' own monitors.
- American Heart Association, 2025, home blood pressure monitoring.
General information only, not medical advice. Whether a monitor suits you, and what a difference between two devices means, are questions for your own clinician.