FBP-A3 and FBP-A3XL
Blood pressure monitor validation evidence
Explore the adult clinical studies supporting FBP-A3 and FBP-A3XL, and check their shared ValidateBP listing.
- Validated populationGeneral Adult
- Validation methodISO 81060-2:2018/AMD1:2020
- Models coveredFBP-A3 and FBP-A3XL
Are the FBP-A3 and FBP-A3XL clinically validated?
Yes. Both FondCircle models appear together on ValidateBP, the U.S. Blood Pressure Validated Device Listing, for General Adult use. The listing identifies ISO 81060-2:2018/AMD1:2020 as the validation standard. This evidence concerns blood pressure measurement accuracy in adults.
Evidence scope
FBP-A3 and FBP-A3XL share one ValidateBP listing for General Adult use under ISO 81060-2:2018/AMD1:2020.
Models covered
FBP-A3 & FBP-A3XL
The listing covers blood pressure measurement accuracy in adults for both models.
For a comfortable fit, select your cuff using the arm-circumference range shown on the product page and cuff label.
Study details
FBP-A3 — adult validation study
The clinical study supporting FBP-A3 is summarized in the public 510(k) summary as 87 adult participants and 258 measurement datasets.
- 87adult participants
- 258measurement datasets
Study details
FBP-A3XL — adult validation study
The study included two cuff sizes: 22–42 cm and 40–52 cm. Of the 91 adults tested, 28 used the 40–52 cm cuff.
Accuracy was evaluated across the two cuff groups together, including participants who used the 40–52 cm cuff.
- 91adults in total
- 272measurement datasets
- 28participants measured with the 40–52 cm cuff
Verification and regulatory status
Check the public listing for both models. FDA clearance and the validated-device listing describe different aspects of the monitor's status.
Regulatory status
FDA 510(k)-Cleared
FBP-A3 and FBP-A3XL are FDA 510(k)-cleared blood pressure monitors. The adult validation scope is described separately on this page.
Public validation listing
ValidateBP · FBP-A3 and FBP-A3XL
The public entry identifies both FondCircle models for General Adult use and the ISO protocol stated above.
Open ValidateBP recordValidation FAQ
Answers about model coverage, cuff evidence, the validation population, and what validation means for home monitoring.
Does the ValidateBP listing cover both FBP-A3 and FBP-A3XL?
Yes. The ValidateBP entry names both FBP-A3 and FBP-A3XL and lists them for General Adult use under ISO 81060-2:2018/AMD1:2020.
Do both models have clinical study evidence?
Yes. The public 510(k) summary reports 87 adult participants and 258 measurement datasets for the study supporting FBP-A3, and 91 adult participants and 272 measurement datasets for the study supporting FBP-A3XL. These are separate study groups.
Was the 40–52 cm cuff included in the A3XL study?
Yes. Of the 91 adults in the study, 28 used the 40–52 cm cuff. The reported accuracy results combine the 22–42 cm and 40–52 cm cuff groups; they are not separate results for the XL cuff alone.
Who does this validation cover?
The ValidateBP listing covers General Adult use for both FBP-A3 and FBP-A3XL.
What validation standard was used?
The listing identifies ISO 81060-2:2018/AMD1:2020, a protocol used to assess clinical investigations of automated blood pressure monitors.
Can either device diagnose hypertension?
No. A home blood pressure monitor provides measurements; it does not diagnose hypertension or replace evaluation by a qualified healthcare professional.
Does the listing mean all cuff sizes come with my monitor?
No. The listing describes the device and cuff options it covers, not the contents of each retail package. Check the selected cuff size and What's in the Box on the product page before ordering.