iHealth BP3L Wireless Blood Pressure Monitor
510(k) K152003
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152003 | Date24 Sep 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- FDA applicant
- Andon Health Co, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The iHealth BP3L Wireless Blood Pressure Monitor is a non-invasive blood pressure measurement device classified as an oscillometric blood pressure monitor. It employs an inflatable upper arm cuff and a silicon pressure sensor to automatically measure systolic, diastolic blood pressure, and pulse rate for clinical or home use.
This device is supplied as a single-use or reusable consumer-grade monitor, intended for pairing with compatible mobile or smart devices via wireless connectivity. It has received FDA 510(k) clearance under Special review (K152003) and is manufactured by Andon Health Co., Ltd. No specific sterility or MRI safety information is provided in the available data.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of blood pressure readings does the iHealth BP3L measure, and how does it determine them?
The iHealth BP3L measures systolic, diastolic blood pressure, and pulse rate using an oscillometric method. It employs an inflatable upper arm cuff and a silicon pressure sensor to automatically detect these readings, making it suitable for both clinical and home monitoring.
Is the iHealth BP3L designed for single-use or can it be reused? Does it require any special handling?
The iHealth BP3L is supplied as a consumer-grade device, meaning it is intended for reusable home or personal use rather than single-use. Since it is not classified as a sterile medical device, no special sterilization or handling procedures are required beyond standard hygiene practices (e.g., cleaning the cuff between uses).
How does the iHealth BP3L connect to other devices, and what kind of devices is it compatible with?
The iHealth BP3L is a wireless blood pressure monitor designed to pair with compatible mobile or smart devices. It relies on wireless connectivity (likely Bluetooth or similar) to transmit readings, allowing users to track their blood pressure data on their smartphones or other supported devices.
What is the regulatory pathway for the iHealth BP3L, and which committee reviewed its submission?
The iHealth BP3L received FDA 510(k) clearance under Special Review (K152003) and was classified as substantially equivalent to a predicate device. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a blood pressure monitoring device.