# K110872: Withings Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Withings
- Decided: May 20, 2011 after 52 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001670 (2000). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090058: YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB, Ya Horng Electronic Co., Ltd. (2009) Summary page 1.
- K102631: KD-931D Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2010) Summary page 1.

## Most influential descendants
- K133125: Withings Blood Presure Monitor (2014), 2 descendants of its own
- K182401: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology (IRT) Thermometer probe, B.O.L.T Pulse Oximeter (SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (2019), 0 descendants of its own
- K171668: Bluetooth blood pressure monitor (2018), 0 descendants of its own

## Indications for use
The Withings Blood Pressure Monitor, Upper Arm Type: BP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9"~17" (22cm~42cm) for Upper Arm type.

Source page: https://510kreport.com/device/K110872
Methodology: https://510kreport.com/methodology