# K133125: Withings Blood Presure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Withings
- Decided: Mar 24, 2014 after 175 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001670 (2000). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110872: Withings Blood Pressure Monitor, Withings (2011) Summary page 4.
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2012) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Jun 11, 2018 · Class II · Z-2829-2018: Device could not meet the requirements for systolic pressure

## Indications for use
The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, aver 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 to 17 inches (22cm-42cm) for Upper Arm type.

Source page: https://510kreport.com/device/K133125
Methodology: https://510kreport.com/methodology