Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who uses this: clinic and practice staff, buyers and procurement staff, and students who need to confirm that a specific blood pressure monitor model has been independently validated for accuracy before it is ordered.
What “validated” means for a blood pressure monitor
A validated blood pressure monitor is a specific model whose accuracy was tested by independent investigators, not the manufacturer, using a standardized international validation protocol and compared against a reference standard such as a mercury manometer with the auscultatory method. The monitor counts as validated when its readings meet or surpass the accuracy requirements of the protocol used (Picone et al., 2020).
Validation is a property of a named model, so the manufacturer name and exact model number are what you check, not the brand. Validation is a separate question from regulatory status: see FDA-approved blood pressure monitors for how clearance differs from a validation listing.
Where to check: validation registries compared
Several online registries list validated monitors. They are run by different bodies and do not apply identical rules, so the result of a search depends on which registry you use.
| Registry | Run by / scope | How it is searched or read | Caveat stated by the source |
|---|---|---|---|
| US Blood Pressure Validated Device Listing (VDL), validatebp.org | Created by an expert group that began meeting in 2015; devices are submitted voluntarily by manufacturers and reviewed by a 13-physician committee, with NORC at the University of Chicago managing submission and review (AMA) | Search by device on validatebp.org | Does not list monitors validated with the European Society of Hypertension protocols (Picone et al., 2020). Determinations are made quarterly (AMA) |
| STRIDE BP, stridebp.org | International listing | Enter the exact model or the manufacturer name and scan the results | “No Results Found” means the monitor may not be validated. A “Preferred Device” ribbon is an extra label, not a requirement for being listed (Picone et al., 2020) |
| Medaval | International listing | Read the “Assessment” section for the monitor | “Not recommended” in the assessment means the monitor is not validated. Star ratings are separate from validated status (Picone et al., 2020) |
| National listings | British and Irish Hypertension Society, Hypertension Canada, German Hypertension Society (Quality Seal Protocol), Japanese Society of Hypertension | Each society’s own list | Registries differ in which validation protocols they accept (Picone et al., 2020) |
What the US listing covers
As of the AMA page last updated 24 July 2023 (checked 1 November 2026), the VDL listed 57 clinically accurate devices, including at-home and in-office upper arm devices, wrist cuff devices, community kiosks and 24-hour ambulatory monitors. Submission and review are free, and the AMA states it receives no funding from device manufacturers or other third parties. Because the count and contents change as quarterly determinations are added, check the live listing rather than relying on this figure.
Pre-order verification checklist
This checklist is an editorial summary of the steps described in Picone et al. (2020) and the AMA page.
- Get the exact manufacturer name and model number from the product box or casing or the specification sheet. If these are missing, the monitor is unlikely to be validated (Picone et al., 2020).
- Search the exact model name on the VDL and on STRIDE BP or another registry that fits your region.
- Cross-check a second registry if the first returns nothing, because manufacturers can market the same monitor under different model names or numbers in different countries.
- Record the result with the registry name, the exact entry and the date you checked, since listings are updated over time.
- Confirm the device type in the listing (upper arm, wrist, kiosk or ambulatory) matches what you intend to order. Experts consider wrist devices less reliable than upper-arm cuffs (Harvard Health, 2020).
What should I verify before placing a first order?
Verify that the exact manufacturer and model number you plan to order appears as validated in at least one registry that accepts the validation protocol used, and note the date. A match on brand alone is not enough, because validation applies to a model. A correctly sized cuff is also part of accurate measurement (Picone et al., 2020); cuff sizing is covered in What is a blood pressure cuff?
What documents should I ask the seller for?
Ask the seller for the manufacturer’s exact model number as it appears on the product and, where the seller claims validation, for the registry entry or published validation study for that same model number. Check that entry yourself in the registry rather than relying on the claim, and record the registry name and date. Instructions for use and calibration information are covered in calibration of blood pressure monitors.
Buying several units: bulk blood pressure monitors
For a multi-unit order, validation is still checked per model, not per order. If an order mixes model numbers, or the supplier substitutes a different model number, each model needs its own registry check, since an identical monitor can carry a different model number in a different country (Picone et al., 2020). Pack or case size and unit of measure are set by each supplier, so take them from the supplier’s own product documentation.
Can small buyers or new businesses open an account?
Account opening is a supplier policy and is not part of device validation, so ask the supplier directly. What a small buyer can do independently is the registry check above, which is free: the VDL charges nothing to submit or review devices and the registry search itself requires no purchase.
What shelf life and lot information should be on the label?
Blood pressure monitors are electronic or mechanical measuring devices rather than consumables, and validation is recorded per model, not per lot. Shelf life, lot and date information, where a product carries it, is set out in the manufacturer’s instructions for use and on the labelling that accompanies the product.
Common mistakes
- Treating “not found” as final. A search can wrongly suggest a monitor is not validated because of typing errors, because a recently validated monitor is not yet listed, because the manufacturer uses a different model number in another country, or because validation data were never published (Picone et al., 2020).
- Matching the brand, not the model. Validation applies to the tested model.
- Using one registry only. Registries accept different protocols; the VDL, for example, excludes monitors validated with the European Society of Hypertension protocols.
- Assuming regulatory clearance equals validation. They answer different questions; see the FDA clearance guide. A study of 972 monitor models sold in Australia found only 6% had been validated (reported by Harvard Health, 2020).
FAQ
Is every monitor on the market validated?
No. The Australian study above reported 6% of 972 models sold there as validated (Harvard Health, 2020).
Where can I check if a model is validated?
Use validatebp.org (US VDL), stridebp.org, Medaval or a national society’s list, and cross-check more than one.
Is a wrist monitor validated if it is listed?
If it is listed as validated, the registry lists it as validated for that device type. The VDL includes wrist cuff devices, though experts consider wrist devices less reliable than upper-arm cuffs.
Sources
- American Medical Association, The validation of BP measurement devices for clinical accuracy, page last updated 24 July 2023, checked 1 November 2026.
- Picone DS, Padwal R, Campbell NRC, et al. How to check whether a blood pressure monitor has been properly validated for accuracy. J Clin Hypertens 2020;22(12):2167-2174, doi:10.1111/jch.14065, checked 1 November 2026.
- Harvard Health Publishing, Is your home blood pressure monitor accurate?, 1 July 2020, checked 1 November 2026.
Related: choosing diagnostic and patient monitoring equipment.
