FBP-A2 evidence library

Clinical validation & device information

Review the study populations, validation method, results, and public device records supporting the FondCircle FBP-A2.

Validated populationsPregnancy and adults with diabetes
Validation methodISO 81060-2:2018/Amd.1:2020
Public device recordsFDA, AccessGUDID, and ValidateBP

Clinical study summaries

The FDA-hosted K232621 summary reports separate clinical validation studies in pregnancy and adults with diabetes. Both were evaluated against ISO 81060-2:2018/Amd.1:2020 criteria.

Pregnancy population

Validation during pregnancy

91pregnant participants
270valid datasets
12–40weeks of pregnancy
ISO 81060-22018/Amd.1:2020 method

Study population 38.5% normotensive pregnancy, 30.8% hypertensive pregnancy, and 30.8% pre-eclampsia.

Result The tested monitor fulfilled both ISO 81060-2:2018/Amd.1:2020 validation criteria for the combined pregnancy cohort.

Results were reported for the combined cohort; this page does not claim separate subgroup validation for hypertensive pregnancy or pre-eclampsia.

Read the FDA-hosted clinical summary

Adults with diabetes

Validation in adults with diabetes

90adults with diabetes
268valid BP dataset pairs
Adultsstudy population with diabetes
ISO 81060-22018/Amd.1:2020 method

Study population Adults with diabetes assessed in a dedicated blood pressure measurement validation study.

Result The tested monitor fulfilled both ISO 81060-2:2018/Amd.1:2020 validation criteria in the diabetes study population.

This is an accuracy-validation statement for blood pressure measurement in the studied population. It is not a claim that the monitor diagnoses, treats, or manages diabetes.

Read the FDA-hosted clinical summary

Why does a different model name appear in the study?

A brief explanation for readers who compare the product name with the source documents.

Some source documents use the manufacturer's model name TMB-2092-G. FondCircle FBP-A2 is identified separately in AccessGUDID and ValidateBP, with supporting manufacturer documentation connecting it to the referenced device family.

Public records

Each link below supports a defined part of the evidence chain: clinical performance, regulatory continuity, exact product identity, or validated-device listing.

Clinical performance · 2023

FDA 510(k) K232621

Contains the pregnancy and diabetes study populations, cuff configuration, accuracy results, and ISO 81060-2 conclusions for TMB-2092-G.

Open FDA record

Current device family · 2024

FDA 510(k) K241351

Special 510(k) record for TMB-2092-G that identifies K232621 as its predicate.

Open FDA record

Exact FondCircle product identity

AccessGUDID · FBP-A2

Public device record for FondCircle FBP-A2, Primary DI 00850070979139.

Open AccessGUDID record

Validated-device listing · exact product

ValidateBP · FBP-A2

Public validated-device listing for the FondCircle FBP-A2 blood pressure monitor.

Open ValidateBP record

Important: This page summarizes blood pressure measurement validation and device records. The FBP-A2 does not diagnose diabetes, gestational hypertension, or pre-eclampsia and is not a substitute for professional medical care. Follow your healthcare professional's monitoring recommendations and seek medical care for concerning readings or symptoms.